Autobahn Therapeutics has initiated the multiple ascending dose (MAD) portion of its Phase I trial to evaluate ABX-002 as a potential adjunctive treatment for major depressive disorder (MDD) patients.
The randomised, double-blind, placebo-controlled, single and multiple ascending doses, food effect and bridging pharmacokinetics (PK) trial have been designed to assess the potent and selective thyroid receptor beta (TRβ)-selective agonist, ABX-002.
The study will evaluate ABX-002’s tolerability, safety, PK, and pharmacodynamics in healthy subjects.
Autobahn chief medical officer Gudarz Davar said: “We are very pleased to have successfully completed the initial single ascending dose (SAD) cohorts of the study that support initiation of the MAD portion of this first clinical trial with ABX-002.
“Despite treatment, more than 50% of patients with MDD experience an inadequate response to their antidepressant. Based on extensive clinical precedence supporting the use of thyroid hormone as an effective augmentation treatment for depression and other illnesses, we have designed ABX-002, an oral therapy, to boost and maintain the response to antidepressant treatment.
“We anticipate reporting data from the SAD and MAD portions of this Phase I study in the second half of 2023, followed by initiation of a Phase Ib assessment of ABX-002 in people with MDD.”
The open-label Phase Ib study will assess the safety and activity of ABX-002 in patients with MDD who did not respond well to their antidepressant.