Autobahn Therapeutics Announces Presentation of ABX-002 Phase 1 Clinical Results at the 2025 ASCP Annual Meeting
'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 www.autobahntx.com.
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.
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