Company to initiate Phase 2 trial of ABX-002 for bipolar depression by yearend 2024
ABX-002 also being evaluated as an adjunctive treatment for major depressive disorder in the ongoing AMPLIFY Phase 2 trial
SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to support initiation of a Phase 2 trial of ABX-002 as an adjunctive treatment for patients with bipolar depression. ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain.
“We are thrilled to expand our depression treatment program with ABX-002 and evaluate its potential to safely address the debilitating symptoms of bipolar depression, a highly prevalent and potentially life-threatening disorder,” said Kevin Finney, Autobahn’s President and CEO. “In the U.S. alone, seven million patients suffer from bipolar disorder and there are limited safe and effective therapies that focus specifically on the depressive symptoms that patients face. Our planned Phase 2 trial is designed to provide proof-of-concept for ABX-002 and inform further clinical development in bipolar depression. With this regulatory clearance, we are excited to advance ABX-002 into a second clinical development program later this year alongside our recently initiated Phase 2 study in major depressive disorder.”
The Phase 2 trial will evaluate ABX-002 as adjunctive therapy in adult patients with depressive episodes associated with bipolar I or bipolar II disorder. Autobahn will evaluate the biological and clinical proof-of-concept for ABX-002 across multiple endpoints in the trial, including changes in energy metabolism in the brain as determined by phosphorus magnetic resonance spectroscopy (31P-MRS) and changes in patients’ depressive symptoms as measured by the Hamilton Depression Rating Scale (HAMD).
ABX-002 is also being evaluated in the company’s ongoing AMPLIFY Phase 2 trial as an adjunctive treatment for patients with major depressive disorder (MDD), with topline data expected in the second half of 2025.
About Autobahn Therapeutics
Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic 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 (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.
About ABX-002
ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on 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. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile.
Contacts
Investors:
Alex Straus
THRUST Strategic Communications
alex@thrustsc.com
Media:
Ryan Flinn
In Like Flinn Communications
ryan@inlikeflinncommunications.com
