US-based biotechnology company Autobahn Therapeutics has begun the AMPLIFY Phase II trial, which is assessing ABX-002 as an adjunctive treatment for major depressive disorder (MDD) in adults.
ABX-002 is a selective thyroid hormone beta receptor agonist designed to enhance the central nervous system (CNS) benefits of thyroid hormone biology.
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The drug has shown positive results in previous studies, including optimised pharmacokinetic properties and a favourable safety profile.
The AMPLIFY trial is a placebo-controlled, double-blind study involving 230 adults with moderate-to-severe depression.
It will assess the tolerability, safety, efficacy and pharmacodynamic effects of ABX-002 when used alongside existing selective serotonin reuptake inhibitor (SSRI) or serotonin-noradrenaline reuptake inhibitor (SNRI) treatments.
The primary measure of success will be the change from baseline on the Hamilton Depression Rating Scale-17 (HAMD-17) after six weeks.
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By GlobalDataSecondary endpoints of the AMPLIFY trial include evaluating changes on the HAMD-29 for atypical depression symptoms and the Montgomery–Åsberg Depression Rating Scale.
Autobahn Therapeutics expects to release topline data from this trial in the second half of next year.
By the end of this year, the company plans to begin another Phase II trial, which will focus on patients with bipolar disorder depression.
Autobahn executive vice-president and head of research and development Gudarz Davar said: “We are thrilled to initiate this Phase II trial of ABX-002, marking a substantially evolved profile for Autobahn as a mid-stage development company progressing multiple clinical development candidates.
“The clinical data we’ve generated with ABX-002 support its promise as a brain-penetrating, centrally active thyromimetic with favourable safety, and give us greater confidence in its potential as a game-changing treatment for depression, especially for patients who remain underserved by today’s treatment options.”
Earlier this year, Autobahn secured $100 of funding to launch two Phase II clinical trials of ABX-002 to treat MDD and bipolar disorder depression.
