Latest news with #Montgomery-ÅsbergDepressionRatingScale
Yahoo
09-07-2025
- Business
- Yahoo
GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule
GH Research (NASDAQ:GHRS) is one of the best-performing NASDAQ stocks according to analysts. On June 20, GH Research announced that it had submitted a complete response to the US FDA regarding the clinical hold on its Investigational New Drug/IND Application for GH001. The submission was made ahead of schedule, which showed the company's commitment to advancing its lead product candidate. The CEO of GH Research, Dr. Velichka Valcheva, pointed out that the response addressed the FDA's requests with comprehensive data and completed toxicology studies. GH001 is GH Research's lead product candidate, which was formulated for mebufotenin (5-methoxy-N,N-dimethyltryptamine or 5-MeO-DMT) administration via a proprietary inhalation approach. The company believes that GH001 has the potential to transform the treatment of treatment-resistant depression/TRD. This belief is supported by the observed clinical activity in their Phase 2b GH001-TRD-201 trial. In this trial, the primary endpoint was met, showing a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline of -15.5 points compared with placebo on Day 8. A biochemist in a laboratory conducting research on a new psychiatric therapy. GH Research (NASDAQ:GHRS) is a clinical-stage biopharmaceutical company that develops treatments for depression in the US. While we acknowledge the potential of GHRS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Business Wire
23-06-2025
- Business
- Business Wire
Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression
LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The Company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data. The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD. Key COMP005 Findings: Efficacy Data (MADRS): Single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points, 95% CI [-5.7, -1.5]; p<0.001 Safety Data (statement provided by the DSMB chair): Based on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study. 4 'The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way,' said Kabir Nath, Chief Executive Officer of Compass Pathways. 'We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses. We remain focused on our goal of transforming the landscape of mental health treatment.' 'As we continue our Phase 3 program, we are very encouraged by the initial positive results and the highly statistically significant and clinically meaningful change in the MADRS score between the arms of the study 6 weeks after a single administration of COMP360,' said Guy Goodwin, MD, Chief Medical Officer of Compass Pathways. 'This progress marks an important milestone for patients living with TRD and highlights the groundbreaking work Compass Pathways is doing to bring innovative treatments to those who have been failed by multiple currently approved available treatment options. This achievement provides hope that they can finally receive appropriate care and live the life they deserve. We are incredibly grateful to the participants, investigators and clinical sites for their invaluable contributions to this study.' About the COMP360 Phase 3 Program The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD). The ongoing COMP005 trial is a randomized, double-blind, placebo-controlled study, which has dosed 258 participants with treatment-resistant depression across 32 sites in the United States and aims to assess the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD. The trial is comprised of three parts: Part A, which has recently concluded and was blinded through 6 weeks; Part B, which remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52. The COMP006 trial, running in parallel to the COMP005 trial, is a randomized, double-blind study with 568 planned participants from North America and Europe and aims to compare the safety and efficacy of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360. The trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52. Compass Pathways anticipates sharing 26-week data for COMP005 once all participants in the COMP006 trial have completed part A of the COMP006 trial. The 26-week data from COMP006 is expected in the second half of 2026. About treatment resistant depression (TRD) The United States is in a mental health crisis, and depression is one of the most common mental health disorders. Depression significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030. An estimated 21 million adults in the United States suffer from major depression, and approximately 9 million are drug treated. Due to the limitations of approved existing MDD medications, approximately one-third of patients with MDD will develop TRD. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as 'may', 'might', 'will', 'could', 'would', 'expect', 'intend', 'plan', 'objective', 'anticipate', 'believe', 'contemplate', 'estimate', 'predict', 'potential', 'continue' and 'ongoing,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our plans and expectations regarding our Phase 3 trials in TRD, including our expectations regarding the time periods during which the 26-week results of the two Phase 3 trials will become available; the potential for the pivotal Phase 3 program in TRD to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our expectations regarding the enrollment of our Phase 3 COMP006 trial; any implication that past results will be predictive of future results; and statements related to the innovative potential of psilocybin treatment in mental health care. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from this Phase 3 study in TRD or the results and safety data from our second Phase 3 study in TRD, COMP006, may not be consistent with the preliminary results to date; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading 'Risk Factors' in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. Securities and Exchange Commission ('SEC'), which are available on the SEC's website at Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof. References Data on file For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55 (03), pp.121-138.
Associated Press
27-05-2025
- Business
- Associated Press
Gilgamesh Pharmaceuticals Announces Positive Topline Phase 2a Results for GM-2505 in Major Depressive Disorder (MDD)
GM-2505, a novel 5-HT2A receptor agonist and 5-HT releaser, demonstrated rapid, robust, and durable antidepressant effect in MDD NEW YORK, May 27, 2025 /PRNewswire/ -- Gilgamesh Pharmaceuticals, a clinical-stage neuroscience company developing innovative, best-in-class new chemical entities (NCEs) that transform the treatment paradigm for psychiatric diseases, today announced Phase 2a results for GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in development for the treatment of patients with moderate-to-severe MDD. The Phase 2a trial was a randomized, double-blind study evaluating the efficacy, safety, and durability of GM-2505 in MDD patients (n=40). Patients were randomized to receive either 10 mg GM-2505 or a low-dose psychoactive comparator of 1 mg GM-2505 via intravenous (IV) infusion on Day 1. All patients were then administered a second dose of 15 mg GM-2505 on Day 15. GM-2505 demonstrated a clinically impactful and statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score as compared to the low-dose psychoactive comparator. In the MMRM analysis, on Day 14, a single 10 mg dose resulted in a -21.6 point change from baseline in MADRS score compared to a -12.1 point change from baseline for the 1 mg low dose (p=0.003), for an estimated effect size of 1.0. On Day 14, 70% of patients receiving 10 mg achieved MADRS remission, defined as a total score of ≤10. On Day 29, following a 15 mg dose, the high dose group (10 mg + 15 mg) demonstrated a -28.0 point change from baseline, with 94% of patients achieving remission. A rapid antidepressant effect was observed within 24 hours, with a -18.5 point change from baseline. A durable MADRS reduction was observed out to Day 74 without any additional treatment. Change from baseline values reported are least squares mean estimates from MMRM analysis Remission is defined as MADRS total score ≤10 GM-2505 was well tolerated with no serious adverse events. The majority of adverse events were mild and typically resolved within two hours following administration. 'The clinical response and remission rates highlight the potential for GM-2505 to be a groundbreaking therapy for patients with MDD. These compelling results are the culmination of five years of research focused on designing and developing truly novel and optimized treatments.' said Jonathan Sporn, MD, Founder and CEO of Gilgamesh Pharmaceuticals. 'GM-2505's rapid and sustained antidepressant effect fits seamlessly into the existing two-hour in-clinic treatment model.' 'The data from this Phase 2a trial are impressive, in particular the large and sustained remission rates. The robust effect size is compelling given the use of a truly psychoactive comparator in this study. Given the modest efficacy of standard antidepressants, it is exciting to see the clinical results of a novel agent targeting the 5-HT2A receptor,' said Maurizio Fava, MD, Chair of the Mass General Brigham Academic Medical Centers Psychiatry Department, Harvard Medical School. 'The magnitude of symptom improvement observed through the MADRS score reductions is truly impressive. The treatment fits nicely in the two-hour in-clinic framework established by esketamine, but with the potential for significantly fewer annual visits. The use of a psychoactive control dose helps to manage the confound of functional unblinding, which is an issue with this class of investigational medicines,' said Gerard Sanacora, MD, PhD, Professor of Psychiatry at Yale University and the Director of the Yale Depression Research Program. Gerard Marek, MD, PhD, the Chief Medical Officer of Gilgamesh Pharmaceuticals, will deliver an oral presentation of the results during the American Society of Clinical Psychopharmacology's annual meeting in Scottsdale, Arizona: About GM-2505: GM-2505 is a novel, best-in-class 5-HT2A receptor agonist designed to provide rapid, robust, and durable antidepressant effects within a short, in-clinic treatment session. It is administered via IV infusion, with an intramuscular formulation planned for future studies. In addition to its primary receptor target, GM-2505 exhibits activity as a 5-HT releaser, which may enhance serotonergic activity and contribute to its therapeutic benefits. GM-2505 is an NCE with issued composition of matter IP. About Major Depressive Disorder: More than 20 million people in the U.S. suffer from MDD. Up to two-thirds of patients do not achieve remission after multiple antidepressants, each of which can take weeks to show efficacy and often cause significant side effects including weight gain, sexual dysfunction, and flattened affect. There is an urgent need for rapid-acting, durable, effective, and well-tolerated treatments. About Gilgamesh Pharmaceuticals: Gilgamesh Pharmaceuticals is a clinical-stage neuroscience biotech developing innovative, best-in-class new chemical entities that transform the treatment paradigm of psychiatric diseases, moving away from symptom management towards rapid-acting and durable therapies. The company designs therapies acting through precedented mechanisms, which are optimized for safety, efficacy, and patient access. Gilgamesh is advancing a diverse portfolio of programs, including two lead clinical programs: GM-2505, which will be moving into late-stage development, and GM-1020 (oral NMDAR antagonist), which is completing a Phase 2a study in Major Depressive Disorder in 2025. Learn more about the company's therapeutic pipeline at Media Contact: [email protected] Investor Contact: [email protected] View original content to download multimedia: SOURCE Gilgamesh Pharmaceuticals
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
Yahoo
19-04-2025
- Health
- Yahoo
Vagus Nerve Stimulation Has Lasting Effects in People With Severe Depression
Stimulating either of a pair of crucial nerves that carry messages from the brain to several major organs could be an effective way to treat people with severe depression. An international team of researchers conducted a clinical trial on 493 adults whose major depression hadn't previously responded to treatment. Participants were fitted with a device capable of stimulating one of their vagus nerves, which was then activated in half the group to transmit signals to areas of their brain that regulate moods. Assessments were carried out for roughly ten months, after which participants who received the stimulation treatment showed improvements in their depressive symptoms, in their quality of life, and in their ability to carry out the daily tasks of everyday life. "On average, each patient had already tried 13 treatments that failed to help them before they enrolled in the trial, and they had spent more than half of their lives sick with depression," says Charles Conway, a professor of psychiatry at Washington University in St Louis. "But despite that super-high level of sustained illness, we still see statistically significant, measurable improvements in depressive symptoms, quality of life and functional outcomes." While VNS has shown promise for treating depression before, evidence of its success hasn't always been clear cut, leaving treatment difficult to afford for many in the US on insurance cover. There are some reasons to be cautious. Based on the study's primary measure of depressive symptoms, the Montgomery-Åsberg Depression Rating Scale (MADRS), there were no differences between the treatment and non-treatment groups. Very few participants from either group reported a full remission in their depression, and it's also worth noting the study was partly funded and supported by LivaNova USA, which manufactures a VNS therapy system for patients. Even with those caveats in mind though, the study's results are promising, particularly when it comes to helping people escape the mental paralysis that can come along with major depression. "What's really important here is that patients themselves were reporting that their lives were improving," says Conway. "They're saying they are seeing meaningful improvements in their ability to function and live their lives." Up to 30 percent of those with severe depression fail to benefit from standard antidepressants, with their mental health problems compounded by an increased risk of suicide, hospitalization, and disability. The same clinical trial is being used to see if VNS can make a difference for people with bipolar too. In addition, the researchers want to continue the trial for another four years, and see if the benefits are particularly noticeable in certain groups of people. "The nice thing about vagus nerve stimulation, we know from other studies, is that when the patient responds, the effects usually stick," says Conway. The research has been published in two papers in Brain Stimulation, here and here. An earlier version of this article was published in January 2025. Weight Gain Might Be Linked to 'Lifestyle Instability', Not Just Calories Up to 13% of Dementia Cases May Actually Be a Misdiagnosed Treatable Condition Study on Mice Suggests Surprising Link Between Nose-Picking And Alzheimer's
