ABX-002 also in Phase 2 development for the adjunctive treatment of major depressive disorder, with topline data from the AMPLIFY study also expected in the second half of 2025

SAN DIEGO – January 8, 2025 – Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the initiation of a Phase 2 clinical trial evaluating ABX-002, its highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist, as an adjunctive treatment in adults with bipolar depression. The Phase 2 trial aims to establish biological and clinical proof-of-concept for ABX-002 in bipolar depression and will inform Autobahn’s further clinical development strategy.

“Bipolar depression is one of the most prevalent and difficult-to-treat psychiatric conditions due to a host of burdensome symptoms,” said Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at University of Toronto. “People living with bipolar disorder often experience prolonged periods of depression, many of whom are not adequately benefiting from, or have had difficulties tolerating, existing treatments. For decades, preclinical and clinical evidence has supported the effectiveness of thyroid hormone as an adjunctive treatment in adults living with bipolar depression, providing the basis for rigorously evaluating an optimized, brain-targeted, potent and selective TRβ agonist which could serve as a highly promising therapeutic option in the future.”

The Phase 2 open-label trial will study ABX-002 as an adjunctive treatment in 30 adult patients with depressive episodes associated with bipolar I and bipolar II disorder and will utilize neuroimaging assessments and validated clinical scales to evaluate changes in metabolites associated with brain energy metabolism and improvements in depressive symptoms. The primary endpoints will be to assess the correlation of change from baseline of nucleoside triphosphate (NTP) and phosphocreatine (PCr) in the brain, as determined by phosphorus magnetic resonance spectroscopy imaging (31P-MRS), with percent change in the Hamilton Depression Rating Scale-17 (HAMD-17) over six weeks of dosing, respectively. Key secondary and exploratory endpoints will evaluate changes from baseline in the HAMD-17, HAMD-29, as well as other neuroimaging assessments, including brain activity as measured by resting state functional magnetic resonance imaging (rs-fMRI). Autobahn anticipates reporting topline data from this study in the second half of 2025.

Source: https://autobahntx.com/news/autobahn-therapeutics-announces-initiation-of-phase-2-trial-of-abx-002-as-an-adjunctive-treatment-for-bipolar-depression/