Fluoxetine Hydrochloride

SNTX-2643 is a novel, investigational, state-selective serotonin transporter modulator being developed for anxiety disorders Company also announces appointment of Cole Brown, M.D., as Chief Medical Officer and formation of a Clinical Advisory Board CAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Sensorium Therapeutics, a clinical-stage central nervous system (CNS) biotechnology company developing mechanistically novel small-molecule medicines for psychiatric and neurological disorders, today announced that it will present the design of its ongoing Phase 1a clinical study of SNTX-2643, along with preclinical mechanistic data, at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 26-29 in Miami Beach, Florida. SNTX-2643 is Sensorium's lead investigational therapy from its SENS-01 program and is being developed for the treatment of anxiety disorders, including social anxiety disorder and generalized anxiety disorder. The compound is a novel, state-selective serotonin transporter (SERT) modulator designed to modulate SERT through a mechanism differentiated from currently marketed selective serotonin reuptake inhibitors (SSRIs). The company also announced the appointment of Cole Brown, M.D., as Chief Medical Officer and the formation of a Clinical Advisory Board comprising leading experts in psychopharmacology, psychiatry, clinical trial design, and CNS drug development. "Behind every statistic on anxiety is a person whose life has been narrowed by it, and far too many remain underserved by the treatments available today," said Jacob Hooker, Ph.D., Co-Founder and Chief Executive Officer of Sensorium Therapeutics. "SENS-01 reflects our commitment to changing that through a mechanistically differentiated approach designed to address limitations patients and clinicians know all too well. The work being presented at ASCP, together with Cole's leadership and the depth of our Clinical Advisory Board, underscores the rigor and clinical discipline guiding this program." ASCP 2026 Presentation Title: The Pharmacokinetic Properties and Target Engagement Effects of the Novel Serotonin Transporter Modulator, SNTX-2643, in Healthy Adults Poster Number: T10 Session: Thursday, May 28, 2026, 11:30 a.m.–1:15 p.m. Eastern Presenting Author: Cole Brown, M.D., Chief Medical Officer, Sensorium Therapeutics Authors: Andrew J. Cutler, M.D.; Cole Brown, M.D.; Jacob Hooker, Ph.D.; Jerry Rosenbaum, M.D. Meeting: ASCP 2026 Annual Meeting Location: Miami Beach, Florida The poster will describe the design of Sensorium's ongoing Phase 1a study of SNTX-2643. The presentation will also include preclinical phosphoproteomic analyses revealing a distinct downstream molecular signature for SNTX-2643 relative to fluoxetine. Topline Phase 1a results are expected in the second half of 2026. "There remains a substantial unmet need for anxiety treatments that can address limitations of current options, including delayed onset, tolerability burden, sedation, and dependence concerns," said Andrew Cutler, M.D., Clinical Professor of Psychiatry, SUNY Upstate Medical University and member of Sensorium's Clinical Advisory Board. "SNTX-2643's differentiated mechanism, together with the design of the ongoing clinical development program, creates an exciting opportunity to deliver a new treatment to help the millions of people and their families suffering with anxiety." About the Phase 1a Study The Phase 1a study of SNTX-2643 is a randomized, double-blind, placebo-controlled, and open-label (food-effect cohort) clinical study designed to characterize the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of SNTX-2643 in healthy adult volunteers following single-dose administration, and to inform the design of subsequent clinical studies. The study includes single-ascending dose cohorts designed to evaluate escalating doses of SNTX-2643; a target engagement cohort using quantitative electroencephalography (qEEG), including resting-state measures, event-related potentials, and an anxiety-inducing stimulus paradigm to characterize CNS target engagement; and a food-effect cohort designed to evaluate the impact of food on the rate and extent of SNTX-2643 absorption. Safety is the primary endpoint of the study. Secondary endpoints include plasma PK, with exploratory endpoints including target engagement and qEEG measures. Cole Brown, M.D., Appointed Chief Medical Officer Dr. Brown will lead clinical development across Sensorium's pipeline. He brings nearly 20 years of experience spanning clinical development, medical affairs, pharmacovigilance, and regulatory affairs across a range of therapeutic areas. Dr. Brown joins Sensorium from Sage Therapeutics, where he served in roles of increasing responsibility within the Research and Development and Commercialization functions, through the company's acquisition by Supernus Pharmaceuticals. Earlier in his career, Dr. Brown led Medical Affairs and Clinical Development at Egalet, which was acquired by Zyla Life Sciences, now Cosette Pharmaceuticals, and worked as an independent consultant advising biotechnology companies. He began his industry career at AlphaGroup, now Red Nucleus, where he contributed to nearly a dozen drug product launches. Dr. Brown serves on the alumni board of Temple University's College of Science and Technology and is Co-Managing Partner of SCD Ventures. "Sensorium has built a disciplined clinical development organization around a discovery platform designed to generate differentiated CNS medicines," said Dr. Brown. "SNTX-2643 is a thoughtfully designed program around new pharmacology for a well-validated target, and I look forward to advancing it through Phase 1 and into patient studies with the rigor this program deserves." Clinical Advisory Board Sensorium's Clinical Advisory Board provides scientific and clinical guidance on the company's development programs, including SNTX-2643 and future pipeline candidates. Founding members include: Andrew J Cutler, M.D. Clinical Professor of Psychiatry, SUNY Upstate Medical University Maurizio Fava, MD Chair, Massachusetts General Brigham Psychiatry Department Douglas Feltner, M.D. Chief Medical Officer, Neurosterix Napoleon Higgins, M.D. CEO and President of Bay Pointe Behavioral Health Service, Inc. K Ranga Krishnan, M.B.B.S. Professor Emeritus, Duke University Sanjay J Mathew, M.D. Department Head, Psychiatry and Behavioral Sciences, Texas A&M College of Medicine Charles B Nemeroff, M.D., Ph.D. Matthew P Nemeroff Endowed Chair, Department of Psychiatry and Behavioral Sciences, University of Texas at Austin, Dell Medical School Raymond Sanchez, M.D. Senior Advisor, Bain Capital Life Sciences and Former Chief Medical Officer, Cerevel Therapeutics Murray B Stein, M.D., M.P.H., FRCPC Distinguished Professor of Psychiatry and Public Health, University of California San Diego Jeffrey R Strawn, M.D., FAACAP Dr. Henry and Amelia Nasrallah Endowed Professor in Psychiatric Neuroscience Professor of Psychiatry & Behavioral Neuroscience University of Cincinnati, College of Medicine Department of Psychiatry & Behavioral Neuroscience About SNTX-2643 (SENS-01 Program) SNTX-2643 is Sensorium's lead investigational therapy from the SENS-01 program and is being developed for social anxiety disorder, with potential applicability to generalized anxiety disorder and multiple other CNS disorders. It is a first-in-class precision serotonin modulator, differentiated from conventional SSRIs, designed for rapid onset, reduced off-target effects, and to avoid the sedation commonly associated with benzodiazepines. About Sensorium Therapeutics Sensorium Therapeutics is a clinical-stage central nervous system (CNS) biotechnology company developing mechanistically novel small-molecule medicines for psychiatric and neurological disorders. The company applies its proprietary SensAI discovery platform, which integrates chemistry, pharmacology, behavioral science, and neuroscience, to systematically predict drug candidates with differentiated mechanisms of action. Founded by researchers from Harvard and Massachusetts General Hospital, Sensorium is advancing a pipeline led by SNTX-2643, a Phase 1 investigational therapy for anxiety disorders. The company's pipeline also includes SENS-03, a preclinical program for treatment-resistant epilepsy, and SENS-08, a National Institutes of Health (NIH)-supported preclinical program targeting cognitive enhancement. For more information, visit . Contact Stefan Riley [email protected] 617-461-2442 This press release contains forward-looking statements regarding Sensorium Therapeutics' development programs, including anticipated clinical development activities, study timing, and potential therapeutic characteristics of investigational candidates. Actual results may differ materially from those expressed or implied by these forward-looking statements due to various risks and uncertainties inherent in drug development. SOURCE Sensorium Therapeutics 21% more press release views with Request a Demo

Autobahn Therapeutics, a San Diego-based biotechnology company, announced receipt of US FDA Fast Track Designation for elunetirom (ABX-002), an oral, once-daily, brain-penetrant CNS thyroid hormone receptor (CNS-TR) agonist, for the adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Elunetirom is the company’s lead asset and has no prior expedited designations on record. Fast Track Designation allows Autobahn more frequent interactions with the US FDA during development and makes elunetirom eligible for Rolling Review of a future marketing application, as well as potential Priority Review and Accelerated Approval if relevant criteria are met at submission. Elunetirom is a small molecule prodrug designed to selectively engage CNS-TRs while limiting peripheral thyroid hormone receptor activity — the principal liability associated with systemic synthetic thyroid hormone administration, such as triiodothyronine (T3). T3 has demonstrated efficacy across multiple placebo-controlled studies in major depressive disorder (MDD) and bipolar depression, providing a validated biological rationale for the CNS-TR target. Elunetirom’s CNS-selective design is intended to capture that activity while avoiding cardiac, bone, and metabolic effects linked to peripheral thyroid hormone exposure. The company’s Phase II AMPLIFY-BD trial (NCT06869187), evaluating elunetirom as an adjunctive bipolar depression treatment, is ongoing, with topline data expected in Q2 2026. A parallel Phase II AMPLIFY trial (NCT06633016) in adjunctive MDD is also active, with topline data expected in Q3 2026. The most recent public clinical data for elunetirom come from a first-in-human Phase I single- and multiple-ascending dose study in healthy volunteers, results from which were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in May 2025. The Phase I data showed no serious adverse events across all dose cohorts, dose-proportional pharmacokinetics supporting once-daily dosing, and evidence of CNS-TR target engagement in brain regions associated with depression. Research context Bipolar depression affects approximately 7 million adults in the US. Approved adjunctive options include quetiapine, lurasidone, cariprazine, and the olanzapine-fluoxetine combination, each carrying liabilities that include weight gain, metabolic effects, movement disorders, and sexual dysfunction. More than half of patients do not achieve adequate relief on available therapies, and the standard of care has not materially changed in decades. Elunetirom’s CNS-TR agonist mechanism is without an approved comparator in psychiatry. Unlike atypical antipsychotics, which act primarily through dopamine and serotonin receptor modulation, elunetirom targets mitochondrial function, cellular energy production, and neuroplasticity through CNS-TR agonism — a distinct biological pathway. No other CNS-selective thyroid hormone receptor agonist is currently approved or, based on available public data, in late-stage development for bipolar depression. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.