Latest news with #MDD
Yahoo
11 hours ago
- Business
- Yahoo
CEO maligns FDA delays over depression device treatments' US market entry
The CEO of Flow Neuroscience has called out the US Food and Drug Administration (FDA) for market entry delays for clinically validated devices for treating depression. The UK company's CEO pointed out that in spite of these delays, the US market is instead 'flooded' with wellness products that lack clinical validation and make 'vague' claims about their ability to 'improve focus' or relieve the symptoms of depression. Transcranial direct current stimulation (tDCS) devices such as the one developed by Flow, which gained a breakthrough device designation from the FDA in 2022, have been proposed as a new treatment in major depressive disorder (MDD). In a recent international clinical trial of Flow's device, the results of which were recently published in Nature Medicine, 57% of patients experienced remission from depressive symptoms and no severe side effects reported, while 92% of participants had a clinically significant response to the treatment. Despite the breakthrough designation, Flow remains unavailable in the US. 'People can easily purchase wellness devices with no clinical evidence behind them, while science-backed companies are still waiting on regulatory approval,' said Flow Neuroscience CEO Erin Lee. 'This kind of regulatory imbalance doesn't just hold back innovation, but ultimately harms patients.' Lee pointed out that the FDA system is 'fundamentally inconsistent' and called its approach 'two standards under one roof' given the FDA demands extensive US-based trials from devices that already meet international medical standards, yet at the same time, companies can 'flood the wellness category with unverified claims and no clinical scrutiny'. A recent whitepaper testifies to this gap. It found that 85-90% of medical devices in the US reach market via the 510(k) pathway, which doesn't require clinical trials, while novel neuromodulation devices like tDCs are typically pushed into De Novo or Premarket Approval routes, requiring multi-year trials even if they have existing international approval. Lee concluded: 'In practice, what this means is that people in Sweden, the UK, or even Hong Kong can access a device like Flow, while Americans are left with expensive gadgets that claim to stimulate the vagus nerve or boost brainwaves, without any evidence.' The FDA did not immediately respond to a request for comment. "CEO maligns FDA delays over depression device treatments' US market entry" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Hamilton Spectator
16 hours ago
- Health
- Hamilton Spectator
Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona. Details of the presentations are as follows: AUVELITY Title: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY®) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations Lead Author: Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the University of Virginia Presentation Date and Time: Wednesday, May 28, 11:15 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session I Poster Number: W25 AXS-05 Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized-Withdrawal Double-Blind Placebo-Controlled Study Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T16 Solriamfetol Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at Witten/Herdecke University, Germany Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T15 About AUVELITY® AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of AUVELITY in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if AUVELITY is safe and effective for use in children. AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? AUVELITY and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: Do not take AUVELITY if you: AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY. Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. Symptoms may include: Unusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). AUVELITY may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. AUVELITY may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: COMMON SIDE EFFECTS The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating. These are not all the possible side effects of AUVELITY. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . BEFORE USING Tell your HCP about all your medical conditions, including if you: Review the list below with your HCP. AUVELITY may not be right for you if: HOW TO TAKE LEARN MORE For more information about AUVELITY, call 866-496-2976 or visit . This summary provides basic information about AUVELITY but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about AUVELITY and how to take it. Your HCP is the best person to help you decide if AUVELITY is right for you. AUV CON BS 10/2022 Please see full Prescribing Information , including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide . About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ('NDA') for any of the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@ Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@
Associated Press
2 days ago
- 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
Yahoo
2 days ago
- Business
- Yahoo
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 Demonstrated robust antidepressant effect with a -21.6 point change from baseline in MADRS total score at Day 14, a 9.6 point greater reduction than a low-dose psychoactive comparator Rapid antidepressant effect observed at 24 hours, with a -18.5 point change from baseline in MADRS Durable efficacy with a -28.0 point change from baseline in MADRS at Day 29 and sustained efficacy to Day 74 without further treatment MADRS remission rate of 70% at Day 14 and 94% at Day 29 GM-2505 was safe and well tolerated with most side effects self-resolving within two hours of dosing Data to be presented at the American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona, May 27 – May 29, 2025 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. MADRS CHANGES FROM BASELINE AND REMISSION RATES ARM 1 ARM 2 GM-2505 DOSINGDay 1, 1 mg Day 15, 15 mg Day 1, 10 mg Day 15, 15 mg BASELINE31.9 33.4 DAY 14 n=20 n=20 - CHANGE FROM BASELINE-12.1 -21.6 - REMISSION25 % 70 % DAY 29 n=20 n=17 - CHANGE FROM BASELINE-21.1 -28.0 - REMISSION55 % 94 % DAY 74 FOLLOW-UPn=20 n=17 - CHANGE FROM BASELINE-19.7 -25.1 Change from baseline values reported are least squares mean estimates from MMRM analysisRemission 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: Robust antidepressant efficacy of the novel 5-HT2A receptor agonist GM-2505 in a double-blind, randomized, controlled Phase 2a trial in patients with MDD Oral Presentation: Tue, May 27, 2025 at 2:30PM MST Poster Presentation: Time: Wed, May 28 from 11:15AM – 1PM MST; Thu, May 29, 2025 from 11:30AM – 1PM MST 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: media@ Investor Contact: laszlo@ View original content to download multimedia: SOURCE Gilgamesh Pharmaceuticals Sign in to access your portfolio
Yahoo
6 days ago
- 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
