Autobahn Therapeutics has announced the initiation of the AMPLIFY Phase 2 clinical trial, evaluating ABX-002 as an adjunctive treatment for adults with major depressive disorder (MDD). This placebo-controlled, double-blind study aims to enroll 230 participants and is designed to assess the safety, tolerability, efficacy, and pharmacodynamic (PD) effects of ABX-002 in conjunction with existing SSRI or SNRI treatments. Topline data is anticipated in the second half of 2025.
ABX-002: A Novel Approach to MDD Treatment
ABX-002 is an orally administered, potent, and selective thyroid hormone beta receptor (TRβ) agonist. It is designed to enhance the central nervous system (CNS) benefits of thyroid hormone biology while minimizing the peripheral liabilities associated with synthetic thyroid hormones like triiodothyronine (T3). Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role in 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.
Trial Design and Endpoints
The AMPLIFY trial's primary endpoint is the change from baseline on the Hamilton Depression Rating Scale-17 (HAMD-17) after six weeks of treatment. Key secondary endpoints include changes from baseline on the HAMD-29 to assess improvements on atypical depression symptoms, the Montgomery–Åsberg Depression Rating Scale (MADRS), and other measures of clinical improvement.
Clinical Significance and Expert Commentary
"Among the millions of people in the U.S. suffering from the debilitating effects of depression, more than half experience an inadequate response to their current antidepressant, underscoring the urgent need for treatment options that provide relief for patients," said Dan Iosifescu, M.D., Professor of Psychiatry at NYU Grossman School of Medicine. "Synthetic thyroid hormone has long been known to provide benefit as an adjunctive treatment for MDD, and a highly potent and selective TRβ agonist may offer the therapeutic benefits of synthetic thyroid hormone, with a safety profile that enables chronic use for optimal patient management."
Future Plans
In addition to the AMPLIFY trial, Autobahn Therapeutics plans to initiate a second Phase 2 trial with ABX-002 in patients with bipolar disorder depression by the end of 2024. This expansion underscores the company's commitment to addressing unmet needs in neuropsychiatric disorders.
About Autobahn Therapeutics
Autobahn Therapeutics is focused on developing restorative treatments for neuropsychiatric and neuroimmunologic disorders. Their pipeline is led by ABX-002, targeting thyroid hormone receptor beta (TRβ) as a potential adjunctive treatment for major depressive disorder and bipolar disorder depression. The company is based in San Diego.
