Advancing ABX-002, a highly potent, selective and centrally active thyromimetic, into Phase 2 clinical trials for patients with major depressive disorder and bipolar disorder depression

Advancing neuroimmunology candidate, ABX-101, a first-in-class, centrally penetrant S1P modulator, into Phase 1 development

Financing led by Newpath Partners with participation from new investors Canaan Partners, Monograph Capital, Insight Partners, and existing investors

July 24, 2024 04:00 AM Pacific Daylight Time

SAN DIEGO–(BUSINESS WIRE)–Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the closing of an oversubscribed $100 million Series C financing led by Newpath Partners, with participation from new investors Canaan Partners, Monograph Capital, and Insight Partners. All of the company’s existing investors participated in the round, including founding investors ARCH Venture Partners and Blue Owl Healthcare Opportunities, as well as BVF Partners, Invus, Samsara BioCapital, Biogen, Bristol Myers Squibb, Pfizer Ventures, Section 32, Alexandria Venture Investments and GT Healthcare Capital Partners.

In conjunction with the financing, Thomas Cahill, M.D., Ph.D., Founder and Managing Partner, and Philip DeSouza, M.D.,Venture Partner, of Newpath Partners joined Autobahn’s Board of Directors, alongside Uwe Schoenbeck, Ph.D., Venture Partner at Canaan Partners, and Bonnie van Wilgenburg, Ph.D., Principal at Monograph Capital.

Proceeds from the Series C will be used to commence two Phase 2 clinical trials for the company’s lead program, ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist that was well-tolerated and demonstrated CNS target engagement in a Phase 1 study. In the second half of 2024, Autobahn plans to initiate Phase 2 trials designed to provide biological and clinical proof-of-concept of ABX-002 as an adjunctive treatment for patients with major depressive disorder (MDD) and patients with bipolar disorder depression. MDD and bipolar disorder are highly prevalent, debilitating and life-threatening mental illnesses that affect more than 20 million people and 7 million people in the U.S. alone, respectively.

“With depression rates reaching historic highs in recent years, there is an urgent need for new and better medicines that alleviate suffering and address the global depression crisis. Autobahn’s CNS pipeline, powered by its brain-targeting chemistry platform, has the potential to meaningfully impact the ways in which these debilitating disorders are treated,” stated Dr. Cahill. “The early clinical data with ABX-002 are encouraging, and we are proud to support the efforts to drive this and other therapeutic candidates through clinical trials. We look forward to working alongside the Autobahn team to help bring forward much-needed, effective therapies for people living with depression and other CNS disorders.”

With the proceeds from this raise, Autobahn will also advance ABX-101, a next-generation, brain-penetrant, oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of neuroimmunologic and neuroinflammatory disorders, into Phase 1 clinical testing. ABX-101 represents a differentiated, highly CNS-penetrant dual S1P modulator that unlocks novel pharmacology in multiple cell types in the brain that are associated with inflammatory diseases. In preclinical studies, ABX-101 demonstrated exceptional CNS exposure and robust centrally mediated treatment effects in well-established animal models, as well as the ability to optimize peripheral immunomodulatory benefits.

“We’ve developed a pipeline of novel programs that leverage validated CNS pharmacology and the ability to enhance drug concentrations directly in the brain, offering greater potency for enhanced efficacy. We’re excited to see this approach play out with ABX-002 – a first-in-class, brain-targeted thyromimetic that builds on the clinical efficacy of T3 in augmenting depression treatments – showing both improved efficacy and safety in early clinical studies,” said Kevin Finney, Autobahn’s President and CEO. “We believe ABX-002 has game-changing therapeutic potential for multiple highly prevalent CNS disorders that are underserved by current treatments, including MDD and bipolar depression. With the support of a premier syndicate and the funds from this raise, we plan to move swiftly into Phase 2. We are also greatly encouraged by early data on ABX-101, which has disease-modifying potential in neuroimmunology. Our vision is to restore brain health and dramatically enhance the lives of patients affected by CNS disorders, and we stand well-positioned with the resources, programs, and technologies to achieve that vision.”

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 disorder 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:
Monique Allaire
THRUST Strategic Communications
monique@thrustsc.com

Media:
Ryan Flinn
In Like Flinn Communications
ryan@inlikeflinncommunications.com

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