Latest news with #AltoNeuroscience
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3 days ago
- Business
- Yahoo
Alto Neuroscience Adds 'Intriguing' Depression Asset Via Over $100 Million Deal
On Tuesday, Alto Neuroscience, Inc. (NASDAQ:ANRO) announced an asset purchase agreement with Chase Therapeutics Corporation for a portfolio of dopamine agonist drug combinations for treatment-resistant depression (TRD), generally defined as a failure on two or more antidepressants. Alto paid Chase Therapeutics an upfront payment of $1.75 million. Chase Therapeutics will be eligible for up to $71.5 million in milestone payments, $41 million of the potential future milestone payments are tied to the product candidates' commercial success. Alto expects its current cash balance to support planned operations into 2028 through five clinical trial readouts across its pipeline most advanced program, ALTO-207 (formerly known as CTC-501), is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for Parkinson's disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 enables rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. Phase 2a trial of CTC-501 Chase Therapeutics completed a Phase 2a trial evaluating CTC-501 in 32 patients with depression. The primary endpoint was achieved in the study. Patients randomized to receive CTC-501 reached a mean dose of 4.1mg per day, with 67% achieving the highest allowable dose of 5mg/day. CTC-501 was generally well tolerated in the maintenance period of the study. CTC-501 demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on depression symptoms as measured by the Montgomery Åsberg Depression Rating Scale or MADRS. CTC-501 also demonstrated significantly greater improvement on the Clinician Global Impression Scale of Severity (CGI-S) compared to placebo. Alto expects to initiate a Phase 2b trial, designed to be a potentially pivotal study, with ALTO-207 in patients with TRD by mid-2026 and report topline data in 2027. Phase 2a Trial For CTC-413 ALTO-208 (or CTC-413) is a fixed-dose combination of pramipexole and aprepitant, an antiemetic, neurokinin-1 (NK-1) receptor antagonist. ALTO-208 is being developed for patients with Parkinson's disease (PD). Chase Therapeutics completed a blinded Phase 2a trial evaluating CTC-413 in 13 patients with PD. The mean tolerated dose of CTC-413 significantly exceeded pramipexole. Six subjects (67%) tolerated CTC-413 at the maximum dose of 9.0mg/day, and all but one remained on that dose throughout the final three-month treatment period. CTC-413 demonstrated favorable safety and tolerability with no unexpected, serious or persistent issues. William Blair reiterated an Outperform rating on Alto Neuroscience, viewing the acquisition of ALTO-207 as an 'intriguing asset.' The firm noted the impressive efficacy of pramipexole in the PAX-D study but also highlighted the possibility of functional unblinding in that study, which may have contributed to the perceived efficacy. Price Action: ANRO stock is trading higher by 2.31% to $2.66 at last check Tuesday Read Next:Photo by fizkes via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Alto Neuroscience Adds 'Intriguing' Depression Asset Via Over $100 Million Deal originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
- Business
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Alto Neuroscience Announces Acquisition of Novel Dopamine Agonist Combination Product Candidate, Adding Late-Stage Readout in Treatment Resistant Depression Within Current Cash Runway
– ALTO-207 (fka CTC-501) is a fixed-dose combination of pramipexole and ondansetron designed to induce rapid antidepressant effects while mitigating dose-limiting adverse events of pramipexole – – Alto has generated proprietary insights on dopamine biomarkers in depression suggesting that direct dopamine receptor activation with ALTO-207 has the potential to be a differentiated therapeutic approach for treatment resistant depression (TRD) – – CTC-501 met primary and secondary endpoints in a completed Phase 2a study in MDD, demonstrating significantly greater improvements on MADRS compared to placebo (Week 8 Cohen's d = 1.1, p<0.05) – – Alto expects to initiate a Phase 2b trial, designed to be a potentially pivotal study, with ALTO-207 in patients with TRD by mid-2026 and report topline data in 2027 – – Cash guidance unchanged; current cash is expected to fund planned operations into 2028, through at least five planned clinical study readouts – – Company to host conference call and webcast today, June 3, at 8 a.m. ET – MOUNTAIN VIEW, Calif., June 03, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that it entered into an asset purchase agreement with Chase Therapeutics Corporation for a portfolio of potentially best-in-class dopamine agonist drug combinations, including ALTO-207, formerly known as CTC-501, for treatment resistant depression (TRD), generally defined as a failure on two or more antidepressants. The most advanced program, ALTO-207 (formerly known as CTC-501), is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson's disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. "The expansion of our pipeline aligns with Alto's mission to drive innovation in psychiatry through novel therapeutic solutions," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "With proprietary insights on dopamine biomarkers in depression that enable targeted neuropsychiatric drug development, we are uniquely positioned to advance ALTO-207, a differentiated, late-stage product candidate with robust clinical effects to date, which are supported with historical pramipexole data. The fixed-dose combination of pramipexole and ondansetron offers a novel treatment strategy designed to optimize for a rapid treatment effect with faster titration, and balance safety and tolerability at high doses. We believe the convenience of a single prescribable agent will also improve compliance and support clinician and patient adoption. Leveraging our targeted biomarker approach to stratify for TRD patients most likely to respond to treatment, we look forward to building on the positive Phase 2a results and initiating a Phase 2b trial, with a potentially pivotal design, by mid-2026." Dr. Etkin continued, "The strategic transaction with Chase Therapeutics allows us to add a major late-stage clinical readout to our pipeline without changing our current cash runway guidance into 2028. Broadly, we believe this opportunity underscores the robust value of our precision platform and bolsters our prospects for long-term growth through driving innovation in psychiatry." Thomas Chase, M.D., President and Chief Executive Officer of Chase Therapeutics Corporation, added, "Supported by the robust clinical effects in our completed Phase 2a study, we believe CTC-501, has the potential to address the critical need for more effective, mechanistically distinct interventions for patients with TRD. Given Alto's expertise in dopamine-related products in depression, we believe they are an ideal partner to maximize the therapeutic potential of our portfolio in depression and Parkinson's disease. We look forward to seeing Alto continue this exciting momentum as they work toward realizing our shared vision for patients." Michael Browning, DPhil, MRCP, MRCPsych, Professor of Computational Psychiatry, University of Oxford, commented, "I am highly encouraged by the recently completed PAX-D study of pramipexole, which suggests a greater and more durable effect than other available TRD treatments. However, pramipexole is not well tolerated and when it is, it requires slow titration due to dose-limiting AEs. The clinical utility of pramipexole would be greatly enhanced by improving the dose-limiting tolerability profile. Emerging data suggests that ALTO-207 could address these challenges, and be well positioned to treat this large and underserved patient population." Alto acquired CTC-501 (now ALTO-207), in development for depression, and CTC-413 (now ALTO-208), in development for Parkinson's disease. Both product candidates are novel patent-protected dopamine agonists. About the Completed Phase 2a Trial for CTC-501 Chase Therapeutics completed a randomized, placebo-controlled Phase 2a clinical trial evaluating CTC-501 in 32 patients with depression. The study consisted of two periods, a dose titration period in which patients were dosed with increasing dose levels of CTC-501 or placebo at increments of 1 mg/day (or matching placebo) until the maximum allowed dose (or first intolerable dose) was reached. Patients were then maintained for an eight-week treatment period at either the maximum allowed dose or their maximum tolerated dose (1 mg/day lower than their first intolerable dose in the titration period). The primary endpoint in the study was defined as overall tolerability and achievement of higher dose levels of pramipexole when combined with ondansetron. Clinical efficacy was evaluated as a secondary exploratory endpoint in the study. The primary endpoint was achieved in the study. Patients randomized to receive CTC-501 reached a mean dose of 4.1mg per day with 67% of patients achieving the highest allowable dose of 5mg/day. CTC-501 was generally well tolerated in the maintenance period of the study. The clinical efficacy measures were evaluated as secondary endpoints and across measures CTC-501 demonstrated large, clinically meaningful, effects. CTC-501 demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on depression symptoms as measured by the Montgomery Åsberg Depression Rating Scalef, or MADRS (LSM Δ vs. placebo at Week 8 = -8.2, p=0.025, Cohen's d=1.1). CTC-501 also demonstrated a significantly greater improvement compared to placebo on the Clinician Global Impression Scale of Severity, or CGI-S (LSM Δ vs. placebo at Week 8 = -0.76, p=0.04, Cohen's d=1.0). About the Completed Phase 2a Trial for CTC-413 ALTO-208 is a fixed-dose combination of pramipexole and aprepitant, an antiemetic, neurokinin-1 (NK-1) receptor antagonist. ALTO-208 is being developed for patients with Parkinson's disease (PD). Chase Therapeutics completed a blinded Phase 2a clinical trial evaluating CTC-413 (pramipexole co-administered with aprepitant) in 13 patients with PD. The study consisted of two periods. Patients in the treatment group were initially titrated to the maximum allowed dose of standard pramipexole extended release (4.5 mg/day). Patients were then switched to CTC-413 until the maximum allowed dose of 9mg/day (or first intolerable dose) was reached. Following three months of maintenance, patients returned to their pre-study regimen for final assessment. The mean tolerated dose of CTC-413 significantly exceeded pramipexole (p<0.001). Six subjects (67%) tolerated CTC-413 at the maximum dose of 9.0mg/day and all but one remained on that dose throughout the final three-month treatment period. CTC-413 demonstrated favorable safety and tolerability with no unexpected, serious or persistent issues. About the Transaction Under the terms of the asset purchase agreement, Alto paid Chase Therapeutics an upfront payment of $1.75 million, and Chase Therapeutics will be eligible for up to an aggregate of $71.5 million in future milestone payments related to prespecified development and commercial milestones. $41 million of the potential future milestone payments are tied to commercial success of the product candidates. Alto's financial guidance remains unchanged. The Company expects its current cash balance to support planned operations into 2028, now through five clinical trial readouts across its pipeline programs. Conference Call and Webcast at 8:00 a.m. ET Today Alto Neuroscience will host a conference call today at 8:00 a.m. ET to discuss the acquisition of a novel dopamine agonist combination product candidate. The call will feature Michael Browning, Professor of Computational Psychiatry at the University of Oxford, and Alan Schatzberg, M.D., Professor of Psychiatry and Behavioral Sciences at Stanford University. To listen to the live webcast, please visit Alto's investor relations website. Participants may register for the call here. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company's website. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "expects," "plans," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ("Platform"); Alto's expectations with regard to the design and results of its clinical trials; the reproducibility of positive clinical data seen in prior trials of CTC-501/ALTO-207; Alto's clinical and regulatory development plans for ALTO-207; the competitive landscape and potential market opportunities for ALTO-207; and Alto's anticipated cash runway. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled "Risk Factors" in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ("SEC") as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website. View source version on Contacts Investor and Media Contact: Mari Purpurainvestors@ media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
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Alto Neuroscience Announces Acquisition of Novel Dopamine Agonist Combination Product Candidate, Adding Late-Stage Readout in Treatment Resistant Depression Within Current Cash Runway
– ALTO-207 (fka CTC-501) is a fixed-dose combination of pramipexole and ondansetron designed to induce rapid antidepressant effects while mitigating dose-limiting adverse events of pramipexole – – Alto has generated proprietary insights on dopamine biomarkers in depression suggesting that direct dopamine receptor activation with ALTO-207 has the potential to be a differentiated therapeutic approach for treatment resistant depression (TRD) – – CTC-501 met primary and secondary endpoints in a completed Phase 2a study in MDD, demonstrating significantly greater improvements on MADRS compared to placebo (Week 8 Cohen's d = 1.1, p<0.05) – – Alto expects to initiate a Phase 2b trial, designed to be a potentially pivotal study, with ALTO-207 in patients with TRD by mid-2026 and report topline data in 2027 – – Cash guidance unchanged; current cash is expected to fund planned operations into 2028, through at least five planned clinical study readouts – – Company to host conference call and webcast today, June 3, at 8 a.m. ET – MOUNTAIN VIEW, Calif., June 03, 2025--(BUSINESS WIRE)--Alto Neuroscience, Inc. ("Alto") (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that it entered into an asset purchase agreement with Chase Therapeutics Corporation for a portfolio of potentially best-in-class dopamine agonist drug combinations, including ALTO-207, formerly known as CTC-501, for treatment resistant depression (TRD), generally defined as a failure on two or more antidepressants. The most advanced program, ALTO-207 (formerly known as CTC-501), is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson's disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. "The expansion of our pipeline aligns with Alto's mission to drive innovation in psychiatry through novel therapeutic solutions," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "With proprietary insights on dopamine biomarkers in depression that enable targeted neuropsychiatric drug development, we are uniquely positioned to advance ALTO-207, a differentiated, late-stage product candidate with robust clinical effects to date, which are supported with historical pramipexole data. The fixed-dose combination of pramipexole and ondansetron offers a novel treatment strategy designed to optimize for a rapid treatment effect with faster titration, and balance safety and tolerability at high doses. We believe the convenience of a single prescribable agent will also improve compliance and support clinician and patient adoption. Leveraging our targeted biomarker approach to stratify for TRD patients most likely to respond to treatment, we look forward to building on the positive Phase 2a results and initiating a Phase 2b trial, with a potentially pivotal design, by mid-2026." Dr. Etkin continued, "The strategic transaction with Chase Therapeutics allows us to add a major late-stage clinical readout to our pipeline without changing our current cash runway guidance into 2028. Broadly, we believe this opportunity underscores the robust value of our precision platform and bolsters our prospects for long-term growth through driving innovation in psychiatry." Thomas Chase, M.D., President and Chief Executive Officer of Chase Therapeutics Corporation, added, "Supported by the robust clinical effects in our completed Phase 2a study, we believe CTC-501, has the potential to address the critical need for more effective, mechanistically distinct interventions for patients with TRD. Given Alto's expertise in dopamine-related products in depression, we believe they are an ideal partner to maximize the therapeutic potential of our portfolio in depression and Parkinson's disease. We look forward to seeing Alto continue this exciting momentum as they work toward realizing our shared vision for patients." Michael Browning, DPhil, MRCP, MRCPsych, Professor of Computational Psychiatry, University of Oxford, commented, "I am highly encouraged by the recently completed PAX-D study of pramipexole, which suggests a greater and more durable effect than other available TRD treatments. However, pramipexole is not well tolerated and when it is, it requires slow titration due to dose-limiting AEs. The clinical utility of pramipexole would be greatly enhanced by improving the dose-limiting tolerability profile. Emerging data suggests that ALTO-207 could address these challenges, and be well positioned to treat this large and underserved patient population." Alto acquired CTC-501 (now ALTO-207), in development for depression, and CTC-413 (now ALTO-208), in development for Parkinson's disease. Both product candidates are novel patent-protected dopamine agonists. About the Completed Phase 2a Trial for CTC-501 Chase Therapeutics completed a randomized, placebo-controlled Phase 2a clinical trial evaluating CTC-501 in 32 patients with depression. The study consisted of two periods, a dose titration period in which patients were dosed with increasing dose levels of CTC-501 or placebo at increments of 1 mg/day (or matching placebo) until the maximum allowed dose (or first intolerable dose) was reached. Patients were then maintained for an eight-week treatment period at either the maximum allowed dose or their maximum tolerated dose (1 mg/day lower than their first intolerable dose in the titration period). The primary endpoint in the study was defined as overall tolerability and achievement of higher dose levels of pramipexole when combined with ondansetron. Clinical efficacy was evaluated as a secondary exploratory endpoint in the study. The primary endpoint was achieved in the study. Patients randomized to receive CTC-501 reached a mean dose of 4.1mg per day with 67% of patients achieving the highest allowable dose of 5mg/day. CTC-501 was generally well tolerated in the maintenance period of the study. The clinical efficacy measures were evaluated as secondary endpoints and across measures CTC-501 demonstrated large, clinically meaningful, effects. CTC-501 demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on depression symptoms as measured by the Montgomery Åsberg Depression Rating Scalef, or MADRS (LSM Δ vs. placebo at Week 8 = -8.2, p=0.025, Cohen's d=1.1). CTC-501 also demonstrated a significantly greater improvement compared to placebo on the Clinician Global Impression Scale of Severity, or CGI-S (LSM Δ vs. placebo at Week 8 = -0.76, p=0.04, Cohen's d=1.0). About the Completed Phase 2a Trial for CTC-413 ALTO-208 is a fixed-dose combination of pramipexole and aprepitant, an antiemetic, neurokinin-1 (NK-1) receptor antagonist. ALTO-208 is being developed for patients with Parkinson's disease (PD). Chase Therapeutics completed a blinded Phase 2a clinical trial evaluating CTC-413 (pramipexole co-administered with aprepitant) in 13 patients with PD. The study consisted of two periods. Patients in the treatment group were initially titrated to the maximum allowed dose of standard pramipexole extended release (4.5 mg/day). Patients were then switched to CTC-413 until the maximum allowed dose of 9mg/day (or first intolerable dose) was reached. Following three months of maintenance, patients returned to their pre-study regimen for final assessment. The mean tolerated dose of CTC-413 significantly exceeded pramipexole (p<0.001). Six subjects (67%) tolerated CTC-413 at the maximum dose of 9.0mg/day and all but one remained on that dose throughout the final three-month treatment period. CTC-413 demonstrated favorable safety and tolerability with no unexpected, serious or persistent issues. About the Transaction Under the terms of the asset purchase agreement, Alto paid Chase Therapeutics an upfront payment of $1.75 million, and Chase Therapeutics will be eligible for up to an aggregate of $71.5 million in future milestone payments related to prespecified development and commercial milestones. $41 million of the potential future milestone payments are tied to commercial success of the product candidates. Alto's financial guidance remains unchanged. The Company expects its current cash balance to support planned operations into 2028, now through five clinical trial readouts across its pipeline programs. Conference Call and Webcast at 8:00 a.m. ET Today Alto Neuroscience will host a conference call today at 8:00 a.m. ET to discuss the acquisition of a novel dopamine agonist combination product candidate. The call will feature Michael Browning, Professor of Computational Psychiatry at the University of Oxford, and Alan Schatzberg, M.D., Professor of Psychiatry and Behavioral Sciences at Stanford University. To listen to the live webcast, please visit Alto's investor relations website. Participants may register for the call here. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company's website. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "expects," "plans," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ("Platform"); Alto's expectations with regard to the design and results of its clinical trials; the reproducibility of positive clinical data seen in prior trials of CTC-501/ALTO-207; Alto's clinical and regulatory development plans for ALTO-207; the competitive landscape and potential market opportunities for ALTO-207; and Alto's anticipated cash runway. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled "Risk Factors" in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ("SEC") as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website. View source version on Contacts Investor and Media Contact: Mari Purpurainvestors@ media@
Business Wire
29-05-2025
- Health
- Business Wire
Alto Neuroscience Presents Data at the 2025 American Society of Clinical Psychopharmacology Annual Meeting Reinforcing Safety and Tolerability Profile for ALTO-300 in Major Depressive Disorder
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. ('Alto') (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced a presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, in Scottsdale, Arizona, held May 27-30, 2025. ALTO-300, also known as agomelatine, is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist being developed at 25mg as an adjunctive treatment in the United States for patients with MDD, characterized by an EEG biomarker. Agomelatine is an approved antidepressant medication at both 25mg and 50mg in Europe and Australia but has not been approved in the United States. In clinical studies, the 50mg dose of agomelatine was associated with low levels of reversible liver enzyme elevations, which were not associated with liver failure. In comparison to the 50mg dose of agomelatine, the 25mg dose has been shown to have similar antidepressant activity while avoiding the rates of liver function test (LFT) elevations associated with the 50mg dose. 'Our ASCP presentation continues to support the unique biomarker opportunity for patient stratification and reinforces the well-established safety and tolerability profile for ALTO-300,' said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. 'Agomelatine has been studied in thousands of patients globally and evidence from meta-analyses and real-world clinical care demonstrates the 25mg dose achieves an optimal balance of antidepressant activity without the concern of LFT elevation. These data are consistent with the positive results from our completed Phase 2a trial, and we are encouraged by the safety and tolerability profile of ALTO-300 in our ongoing Phase 2b trial in patients with major depressive disorder. Taken together, we believe the selected 25mg dose of ALTO-300 is well positioned to demonstrate clinical effects while avoiding the low LFT elevation rates associated with the 50mg dose, which typically occur early, are non-cumulative, resolve quickly, and are not associated with liver failure.' Summary of Data Presented ALTO-300 Safety and Tolerability Profile The most common adverse event observed in the completed Phase 2a trial of ALTO-300 was headache. Additionally, the Phase 2a and Phase 2b trials have involved monitoring for elevated liver enzymes (≥ 3 times the upper limit of normal), with the Phase 2b trial including a stopping rule for elevated liver enzymes. No LFT elevations ≥ 3 times the upper limit of normal were observed in the Company's 239-patient completed Phase 2a trial, and no patients have been stopped in the ongoing Phase 2b trial due to liver enzyme elevation, which remains blinded. ALTO-300 EEG Biomarker The ALTO-300 biomarker signal likely reflects increased neural noise due to elevated 5-HT2C tone and reduced dopaminergic activity. Increasing 5-HT2C activity in a preclinical rodent model or directly depleting dopamine in a healthy human volunteer study—both the oppositive mechanistic effect of ALTO-300—resulted in greater EEG irregularity, consistent with a biomarker positive profile. These data reinforce the direct link between ALTO-300 and the EEG biomarker used to identify MDD patients who are more likely to be responders to treatment. The following poster presented at ASCP 2025 is available under ' Publications ' in the platform section of Alto's website: ALTO-300 as Adjunctive Treatment for Major Depressive Disorder Supported by Mechanistic Validation of Patient Selection Biomarker and Well-Established Safety and Tolerability Profile Poster First Author: Michael Avissar, Ph.D. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'expects,' 'plans,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, and effectiveness of its product candidates, biomarkers, and Precision Psychiatry Platform ('Platform'); and Alto's expectations with regard to the design and results of its clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled 'Risk Factors' in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
Business Wire
14-05-2025
- Business
- Business Wire
Alto Neuroscience Reports First Quarter 2025 Financial Results and Recent Business Highlights
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. ('Alto') (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today reported financial results for the first quarter ended March 31, 2025, and highlighted recent progress across its pipeline of clinical-stage product candidates. 'In the first quarter of 2025 we took important steps to deliver on our clinical and corporate objectives,' said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. 'We have continued to execute across each of our four ongoing clinical trials, and in addition we have advanced our biomarker platform to further support our precision psychiatry approach. We believe the recent presentation of our EEG-based placebo response biomarker and dopamine-related biomarkers highlight our leadership position in targeted neuropsychiatric drug development. We look forward to exploring opportunities to maximize the therapeutic impact of our platform to address the high unmet needs of patients. With a strong balance sheet expected to support several key clinical milestones in the coming years, we believe we are well positioned to redefine how neuropsychiatric conditions are treated.' Pipeline Highlights ALTO-100: Enrollment ongoing in Phase 2b bipolar depression trial; data expected in the second half of 2026. ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neuroplasticity, is in development for the treatment of bipolar depression (BPD) in patients characterized by a cognitive biomarker. Enrollment in the randomized, double-blind, placebo-controlled Phase 2b trial remains ongoing with topline data expected in the second half of 2026. The Company expects to enroll approximately 200 patients with BPD. Patients will be evaluated over a six-week treatment period and the primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) in the patient population characterized by a cognitive biomarker. In the fourth quarter of 2024, the Company completed the Phase 2b trial evaluating ALTO-100 as a treatment for major depressive disorder (MDD). The clinically meaningful signal in the adjunctive subgroup and evidence of biomarker enrichment in the compliant subset of patients supports the ongoing Phase 2b trial of ALTO-100 as an adjunctive treatment in BPD. The Company presented additional analyses of the ALTO-100 MDD Phase 2b trial at the Society of Biological Psychiatry (SOBP) Annual Meeting highlighting the utilization of an EEG-based biomarker to account for potential placebo responders. As presented, these results build on the Company's successful identification and prospective replication of an EEG-based biomarker for placebo response in MDD. The analysis prospectively demonstrated that weighting patient outcomes based on an EEG marker for placebo response resulted in a larger treatment response. These data demonstrate the applications of this biomarker to potentially enable more precise identification of high placebo responders and improve detection of treatment response in a clinical trial. The Company expects to employ this biomarker in the ongoing ALTO-100 BPD trial. ALTO-300: Enrollment ongoing in Phase 2b adjunctive major depressive disorder trial; data expected in mid-2026. ALTO-300, also known as agomelatine, is an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist, and is being developed at 25mg as an adjunctive treatment in the United States for patients with MDD, characterized by an EEG biomarker. Agomelatine is an approved antidepressant medication in Europe and Australia, at both 25mg and 50mg, but has not been approved in the United States. In comparison to the 50mg dose of agomelatine, the 25mg dose has been shown to have equivalent antidepressant efficacy and has not been associated with reversible, low liver enzyme elevations observed with the 50mg dose. Topline data from the double-blind, placebo-controlled, randomized Phase 2b trial is expected in mid-2026. The Company expects to enroll approximately 200 biomarker positive patients for the final analysis sample. The final analysis sample is based on the favorable outcome from the interim analysis announced in February 2025, which resulted in a recommendation to continue the study and increase the biomarker positive sample by approximately 50 subjects. While the trial includes both biomarker positive and biomarker negative patients, the primary analysis will be conducted in the biomarker positive subgroup. In the ongoing Phase 2b trial, patients who have had an inadequate response to their current antidepressant are randomized to receive either 25mg of ALTO-300 or placebo over a six-week treatment period. The study medication is being taken in addition to a patient's background antidepressant. The primary outcome is the change from baseline in MADRS score in patients with the EEG biomarker. Across the Company's clinical trials, and in clinical practice, agomelatine has demonstrated a favorable safety and tolerability profile. The most common adverse event observed in the Phase 2a trial of ALTO-300 was headache. Additionally, the Phase 2a and Phase 2b trials have involved monitoring for elevated liver enzymes (≥ 3 times the upper limit of normal), with the Phase 2b trial including a stopping rule for elevated liver enzymes, as measured by liver function tests (LFT). No LFT elevations ≥ 3 times the upper limit of normal were observed in the Company's 239-patient completed Phase 2a trial, and no patients have been stopped in the ongoing Phase 2b trial due to liver enzyme elevation. Across three large, United States-based clinical trials in MDD, the 25mg dose of agomelatine (being developed by the Company as ALTO-300) has not led to liver enzyme elevation, exhibiting rates similar to placebo. Evidence from meta-analyses and real-world clinical care reinforces the consistent safety of the 25mg dose and suggests that higher doses of agomelatine do not result in greater efficacy. The Company believes these data support development of the 25mg dose to optimize clinical efficacy while balancing safety and tolerability. The Company presented new data at SOBP highlighting the mechanistic link between ALTO-300 and the machine learning-derived, EEG biomarker, used to identify patients who are more likely to respond to treatment. Increasing 5-HT2C activity or directly depleting dopamine—both the opposite mechanistic effect of ALTO-300—resulted in greater EEG irregularity, consistent with a biomarker positive profile. ALTO-203: Enrollment completed in Phase 2 proof-of-concept MDD trial; data expected in the second quarter of 2025. ALTO-203, a novel, oral small molecule designed to uniquely act as a histamine H3 inverse agonist, is being developed for the treatment of MDD associated with increased levels of anhedonia. In February, the Company completed enrollment in the 69-patient Phase 2 proof-of-concept (POC) trial in MDD patients with higher levels of anhedonia and expects to report topline data in the second quarter of 2025. The trial is the first evaluation of ALTO-203 in a patient population and consists of two sequential, double-blind, placebo-controlled treatment periods to evaluate two different dose levels of ALTO-203 as a monotherapy. In the first period, patients receive two single-doses of ALTO-203 (high-dose and low-dose), and placebo in a randomized, three-way crossover design, and the outcome measures are designed to evaluate pharmacodynamic effects. An acute change in positive emotion is assessed by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS), an established scale of subjective emotion. The trial is designed to broadly explore the effects of ALTO-203 and is not powered to detect statistical significance on clinical depression outcome scales (e.g., MADRS). In the second period, patients receive high-or low-dose ALTO-203 or placebo once-daily over a 28-day treatment period to further explore the safety and pharmacokinetics of ALTO-203. Pharmacodynamic effects on cognition, EEG, and wearable measures will be evaluated to characterize the profile of ALTO-203 and guide next steps in development. The Company presented new preclinical data at SOBP demonstrating the distinct behavioral effects of ALTO-203, which may be driven by enhanced function and control of dopamine in the reward system. ALTO-203 effectively reversed anhedonia-like behavior induced by dopamine depletion and demonstrated a significantly higher sucrose preference. Pitolisant, the only FDA approved H3R inverse agonist, showed no significant effect at any dose. ALTO-101: Enrollment is ongoing in Phase 2 proof-of-concept CIAS trial; data expected in the second half of 2025. ALTO-101, a brain-penetrant PDE4 inhibitor designed as a novel transdermal formulation, is being developed for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). The novel formulation is designed to retain the desired brain effects shown with the oral formulation while avoiding the tolerability challenges and adverse effects known to be associated with PDE4 inhibitors. Enrollment remains ongoing in the Phase 2 POC trial in CIAS, with topline data expected in the second half of 2025. The Phase 2 POC trial consists of a dose-escalating treatment with ALTO-101 and is designed to enroll approximately 70 adult participants with schizophrenia between the ages of 21 and 55. The primary outcome in the study is the effect of ALTO-101 on theta band activity, the EEG measure shown to be most clearly associated with CIAS in replicated analyses of large schizophrenia datasets. Objective cognitive performance is also evaluated. A poster was presented at the Annual Congress of the Schizophrenia International Research Society (SIRS), demonstrating ALTO-101 significantly enhanced theta responses in humans. Additionally, the Company presented new preclinical data at SOBP, exhibiting increased theta response in a preclinical rescue study with ALTO-101. The Company believes these data underscore the robustness of theta response as a translational biomarker for CIAS and the potential pro-cognitive drug effect. Upcoming Milestones and Events Near-Term Expected Milestones 2Q 2025 — ALTO-203 Phase 2 POC MDD trial topline data 2H 2025 — ALTO-101 Phase 2 POC CIAS trial topline data Mid-2026 — ALTO-300 Phase 2b MDD trial topline data 2H 2026 — ALTO-100 Phase 2b BPD trial topline data Upcoming Conferences The Company is expected to present at the following upcoming conferences: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting: May 27-30, 2025 Jefferies Healthcare Conference: June 3-5, 2025 H.C. Wainwright 6 th Annual Neuro Perspectives Hybrid Conference: June 16-17, 2025 Biotechnology Innovation Organization (BIO) International Convention: June 16-19, 2025 First Quarter 2025 Financial Highlights Cash Position: As of March 31, 2025 the Company had cash, cash equivalents, and restricted cash of approximately $161.3 million, compared to approximately $168.7 million in cash, cash equivalents, and restricted cash as of December 31, 2024. The Company expects its cash balance to support planned operations into 2028. R&D Expenses: Research and development expenses for the quarter ended March 31, 2025 were $10.0 million, as compared to $10.0 million for the same period in 2024. G&A Expenses: General and administrative expenses for the quarter ended March 31, 2025 were $5.7 million, as compared to $4.4 million for the same period in 2024. The increase was primarily attributable to costs associated with higher headcount to support expanded clinical development efforts, growing operational requirements, and costs associated with operating as a public company. $0.3 million of the increase is related to non-cash, stock-based compensation. Net Loss: The Company incurred a net loss of $15.2 million for the quarter ended March 31, 2025, as compared to $13.4 million for the quarter ended March 31, 2024. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'look forward,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations with regard to the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ('Platform'); Alto's expectations with regard to the design and results of its research and development programs and clinical trials, including the timing of enrollment and the timing and availability of data from such trials; Alto's clinical and regulatory development plans for its product candidates, including the timing or likelihood of regulatory filings and approvals for its product candidates; Alto's business strategy, financial position and the sufficiency of its financial resources to fund its operations through expected milestones; and other statements that are not historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of Alto's product candidates; the risk that Alto may not realize the intended benefits of its Platform; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; the risk that Alto's projections regarding its financial position and expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website. ALTO NEUROSCIENCE, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) (unaudited) Three months ended March 31, 2025 2024 Operating expenses: Research and development $ 9,974 $ 9,952 General and administrative 5,702 4,434 Total operating expenses 15,676 14,386 Loss from operations (15,676 ) (14,386 ) Other income (expense): Interest income 1,827 1,558 Interest expense (598 ) (346 ) Loss on debt extinguishment (681 ) — Other, net (41 ) (243 ) Total other income, net 507 969 Net loss $ (15,169 ) $ (13,417 ) Other comprehensive income (loss): Change in fair value attributable to instrument specific credit risk 134 — Foreign currency translation (19 ) (5 ) Total other comprehensive income (loss) $ 115 $ (5 ) Comprehensive loss $ (15,054 ) $ (13,422 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.56 ) $ (0.76 ) Weighted-average number of common shares outstanding, basic and diluted 27,049 17,600 Expand ALTO NEUROSCIENCE, INC. Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) March 31, December 31, 2025 2024 Cash, cash equivalents, and restricted cash $ 161,254 $ 168,729 Total assets 171,915 177,542 Total liabilities 32,819 26,082 Accumulated deficit (153,565 ) (138,396 ) Expand
