SAN DIEGO – NOVEMBER 29, 2022 – Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced the initiation of dosing in the company’s Phase 1 clinical trial of ABX-002 in healthy volunteers. ABX-002 is a potent and selective, brain-boosting thyroid receptor beta (TRβ) agonist that Autobahn is evaluating as a potential adjunctive treatment for people with major depressive disorder (MDD) who are experiencing an inadequate response to their antidepressant.
“We are thrilled to announce the initiation of our first clinical study with ABX-002, marking an important milestone for Autobahn and the millions of patients living with depression around the world,” said Kevin Finney, president and chief executive officer. “There is a wealth of published literature highlighting the effective use of thyroid hormone in treating depression. These historical data, coupled with our preclinical data demonstrating the potent and selective ability of ABX-002 to engage depression-relevant target tissues in the brain, are highly encouraging. We look forward to advancing ABX-002 in the clinic as we further our understanding of its potential impact for patients.”
Despite available treatments, as many as 50% of patients experience an inadequate response to antidepressant therapy . Thyroid hormone has been shown to provide benefit in clinical trials when added to existing antidepressant treatment in patients with MDD and other forms of depression. Widespread clinical use of thyroid hormone to augment antidepressant treatment and the inclusion of thyroid hormone use in most Clinical Treatment Guidelines for depression further support its role as a valuable tool in the therapeutic armamentarium for MDD. Uniquely, rather than being an additive antidepressant mechanism, some experts believe that thyroid hormone may directly affect brain physiology, thereby ‘boosting’ the antidepressant treatment response in patients with MDD who have had an inadequate response.
ABX-002 is an orally administered, potent, selective thyroid hormone agonist that is brain enhanced, demonstrates target engagement in brain regions associated with depression, and has reduced peripheral liabilities when compared with synthetic thyroid hormone, T3, used at its therapeutic dose. ABX-002, like thyroid hormone, is expected to augment and ‘boost’ antidepressant treatments by potentiating the beneficial effects of these drugs on monoaminergic signaling in the brain.
Gudarz Davar, M.D., chief medical officer, added, “Despite available therapies, millions of people around the world continue to suffer from debilitating depression symptoms. We believe that ABX-002, a daily oral pill, combined with antidepressants, could offer patients, caregivers and physicians a much-needed new option that may enhance and maintain treatment response in people living with an inadequate response to their antidepressant.”
The Phase 1 trial is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose, plus food effect and bridging PK study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABX-002 in healthy volunteers. Following completion of the multiple-ascending portion of the study, Autobahn plans to initiate an open label, Phase 1b patient cohort, as part of this study, to explore the safety and potential effects of ABX-002 in patients diagnosed with MDD who have had an inadequate response to their antidepressant.
About Major Depressive Disorder (MDD)
MDD is the third most common cause of disability worldwide, and leaves patients to suffer from an exasperated state of helplessness, grief and increased suicidality. The cause of MDD is not fully understood but has centered around disruption of the monoaminergic system (e.g., serotonin and norepinephrine activity). Approved drugs that enhance monoaminergic signaling in the brain have shown beneficial effects in MDD, but many patients continue to suffer from an inadequate response to treatment that sustains their depressive symptoms and disability.
About Autobahn Therapeutics
Autobahn Therapeutics is focused on restoring hope for people affected by CNS disorders. Leveraging its proprietary brain-targeting chemistry platform, Autobahn aims to unlock new therapeutic opportunities through precision tuning of the central exposure of its molecules. The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta agonist, being developed as a potential adjunctive treatment for people with MDD, including those who have had an inadequate response to their antidepressant. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.
Alicia Davis, THRUST Strategic Communications
 Rafeyan R, Papakostas GI, Jackson WC, Trivedi MH. Inadequate Response to Treatment in Major Depressive Disorder: Augmentation and Adjunctive Strategies. J Clin Psychiatry. 2020 May 12;81(3):OT19037BR3. doi: 10.4088/JCP.OT19037BR3. PMID: 32412697.