Autobahn Therapeutics Advances ABX-002, its Lead Oral Treatment for Major Depressive Disorder, into Multi-Ascending Dose Portion of Phase 1 Trial

ABX-002 was Well-tolerated in Healthy Volunteers in Completed Single Ascending Dose Cohorts, Supporting Continued Clinical Advancement

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company leveraging its brain-targeting chemistry platform, validated biology and biomarker-driven strategies to develop restorative treatments for people affected by CNS disorders, today announced that it has initiated the multiple ascending dose (MAD) portion of its Phase 1 study of ABX-002 in healthy subjects. Autobahn is evaluating ABX-002, a potent and selective thyroid receptor beta (TRβ)-selective agonist, as a potential adjunctive treatment for people with major depressive disorder (MDD).

“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,” said Gudarz Davar, M.D., chief medical officer of Autobahn. “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 believe this could offer significant benefit to the millions of patients suffering from MDD. We anticipate reporting data from the SAD and MAD portions of this Phase 1 study in the second half of 2023, followed by initiation of a Phase 1b assessment of ABX-002 in people with MDD.”

The Phase 1 trial is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose, food effect and bridging pharmacokinetics (PK) study designed to evaluate the safety, tolerability, PK, 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 activity 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 ABX-002
ABX-002 is an orally administered, potent, selective thyroid hormone beta (TRβ) 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.

About Autobahn Therapeutics
Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neurodegenerative clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. 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
alicia@thrustsc.com