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Business Wire
6 days ago
- 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.
Yahoo
27-05-2025
- Business
- Yahoo
Neuphoria to Present at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
BURLINGTON, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) ('Neuphoria' or the 'Company'), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced an upcoming presentation at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting. Presentation details: Title: Pharmacokinetic/Pharmacodynamic Analysis of the BNC210 Attune Phase 2b Dataset Enables Dose Selection for Planned Phase 3 PTSD Study Presenter: Spyros Papapetropoulos, M.D., Ph.D., Neuphoria President and CEO Type: Oral presentation Location: ASCP 2025 Annual Meeting, Fairmont Scottsdale Princess Salon Ballroom H, Scottsdale, AZ Session: Individual research reports Date: Wednesday, 28th May, 2025 Time: 3:40-4:00 pm MST FOR FURTHER INFORMATION PLEASE CONTACT: GeneralSpyridon (Spyros) Papapetropoulosinfo@ Investor RelationsKevin Gardnerkgardner@ About Neuphoria Therapeutics (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, 'as needed' treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer's disease and other central nervous system conditions. Neuphoria's pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage. Forward-Looking StatementsNeuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as 'may,' 'could,' 'will,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'intend,' 'predict,' 'seek,' 'contemplate,' 'potential,' 'continue' or 'project' or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria's ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Neuphoria's financial resources, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company's business and other risks described in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K, Quarterly Report on Form 10-Q, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria's filings with the SEC, copies of which are available from the SEC's website ( and on Neuphoria's website ( under the heading 'Investor Center.' All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
Yahoo
23-05-2025
- Business
- Yahoo
Autobahn Therapeutics Announces Presentation of ABX-002 Phase 1 Clinical Results at the 2025 ASCP Annual Meeting
Poster presentation to highlight Phase 1 results that support ABX-002 Phase 2 development as an adjunctive treatment for major depressive disorder and bipolar disorder depression SAN DIEGO, May 23, 2025--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the company will present the clinical results from its completed Phase 1 trial of ABX-002 at the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 27-30, 2025, in Scottsdale, AZ. ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology for patients suffering from major depressive disorder (MDD), bipolar disorder depression, and other affective illnesses. "We are excited to share the Phase 1 findings at ASCP, which demonstrated a favorable safety and tolerability profile and enhanced CNS target engagement with ABX-002, and support its evaluation in the ongoing Phase 2 trials in major depressive disorder and bipolar depression," said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn. "Despite availability of existing therapies, many individuals with MDD and bipolar depression struggle to achieve adequate relief. Our team remains deeply committed to developing novel, CNS-targeted treatments that we believe have the potential to meaningfully improve the lives of those affected by these debilitating conditions." Results from the completed Phase 1 trial of ABX-002 in healthy volunteers demonstrated ABX-002 was safe and well tolerated, with no serious adverse events observed. Additionally, ABX-002 demonstrated dose proportional PK and clinical evidence of CNS target engagement consistent with brain-activating thyroid effects, helping inform Phase 2 dose selection. The company is currently evaluating ABX-002 as a potential adjunctive treatment for people with major depressive disorder in the ongoing AMPLIFY Phase 2 trial and as a potential adjunctive treatment for bipolar depression in a separate ongoing Phase 2 trial. Details for the poster presentation can be found below: Title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Novel Thyromimetic ABX-002 in Healthy Adult ParticipantsDate: Thursday, May 29, 2025Time: 11:30 a.m. – 1:15 p.m. MTPresenter: Bridgette Franey, M.D., Senior Medical Director, Global Medical Lead - Clinical Development, Autobahn TherapeuticsLocation: Fairmont Scottsdale Princess, Scottsdale, AZ The abstract and additional details can be found on the 2025 ASCP annual meeting website. About Autobahn TherapeuticsAutobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company's pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit About ABX-002ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile. View source version on Contacts Investors: Alex StrausTHRUST Strategic Communicationsalex@ 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
23-05-2025
- Health
- Yahoo
Vistagen to Present at the 2025 American Society of Clinical Psychopharmacology Conference
Posters Highlight New Insights into Social Anxiety Disorder and the Novel Mechanism of Action of Itruvone to Treat Major Depressive Disorder SOUTH SAN FRANCISCO, Calif., May 23, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will present at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025. The Company's poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and the impact of itruvone – the company's investigational pherine for the treatment of major depressive disorder – on the electrogram of nasal chemosensory receptors (EGNR) and the olfactory bulb electrogram (EBG), both biomarkers of itruvone's effect on nasal chemosensory neurons and olfactory bulb physiologic activation. Poster Presentations: Date: Wednesday, May 28, 2025, 11:15 a.m. – 1:00 p.m. Eastern TimeTitle: Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal SprayAuthors: Ester Salmán, MPH; Ross A. Baker, PhD; Stephen D. Coffey, BA; Rita Hanover, PhD; Michael R. Liebowitz, MD; and Louis Monti, MD, PhDPoster Number: W5 Date: Thursday, May 29, 2025, 11:30 a.m. - 1:00 p.m. Eastern TimeTitle: Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors Followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy SubjectsAuthors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; and Rita Hanover, PhDPoster Number: T73 These posters will be available on the Publications page of Vistagen's website on Monday, June 2, 2025. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at View source version on Contacts Investor Inquiries: Mark A. McPartlandmarkmcp@ Media Inquiries: Michelle P. Wellingtonmwellington@ 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
Business Wire
23-05-2025
- Business
- Business Wire
Autobahn Therapeutics Announces Presentation of ABX-002 Phase 1 Clinical Results at the 2025 ASCP Annual Meeting
SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the company will present the clinical results from its completed Phase 1 trial of ABX-002 at the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 27-30, 2025, in Scottsdale, AZ. ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology for patients suffering from major depressive disorder (MDD), bipolar disorder depression, and other affective illnesses. 'We are excited to share the Phase 1 findings at ASCP, which demonstrated a favorable safety and tolerability profile and enhanced CNS target engagement with ABX-002, and support its evaluation in the ongoing Phase 2 trials in major depressive disorder and bipolar depression,' said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn. 'Despite availability of existing therapies, many individuals with MDD and bipolar depression struggle to achieve adequate relief. Our team remains deeply committed to developing novel, CNS-targeted treatments that we believe have the potential to meaningfully improve the lives of those affected by these debilitating conditions.' Results from the completed Phase 1 trial of ABX-002 in healthy volunteers demonstrated ABX-002 was safe and well tolerated, with no serious adverse events observed. Additionally, ABX-002 demonstrated dose proportional PK and clinical evidence of CNS target engagement consistent with brain-activating thyroid effects, helping inform Phase 2 dose selection. The company is currently evaluating ABX-002 as a potential adjunctive treatment for people with major depressive disorder in the ongoing AMPLIFY Phase 2 trial and as a potential adjunctive treatment for bipolar depression in a separate ongoing Phase 2 trial. Details for the poster presentation can be found below: Title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Novel Thyromimetic ABX-002 in Healthy Adult Participants Date: Thursday, May 29, 2025 Time: 11:30 a.m. – 1:15 p.m. MT Presenter: Bridgette Franey, M.D., Senior Medical Director, Global Medical Lead - Clinical Development, Autobahn Therapeutics Location: Fairmont Scottsdale Princess, Scottsdale, AZ The abstract and additional details can be found on the 2025 ASCP annual meeting website. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company's pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit About ABX-002 ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile.
