Autobahn plans to evaluate ABX-002 in major depressive disorder patients in a prospective Phase II trial. Credit: kan_chana / Shutterstock.com.

Autobahn Therapeutics has reported positive topline data from a Phase I clinical trial of ABX-002 in healthy subjects to potentially treat major depressive disorder (MDD).

The double-blind, randomised, placebo-controlled trial evaluated the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of oral, once-a-day, escalating doses of ABX-002.

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It enrolled a total of 48 subjects in the single ascending dose (SAD) and multiple ascending dose (MAD) portions of the trial.

According to the trial data, various tested doses of ABX-002 were found to be safe and well-tolerated.

No serious adverse events were reported, with ABX-002 showing satisfactory dose-relative PK across both portions of the study.

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A top dose of the therapy showed brain target engagement (mood alteration) observed in the MAD section, which is in line with brain-activating thyroid effects.

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Based on this data, the company plans to file an investigational new drug (IND) application with the US Food and Drug Administration to launch a Phase II trial of ABX-002 in the first half of next year.

Autobahn will evaluate ABX-002 as an adjunctive therapy for MDD patients in the Phase II trial.

A selective thyroid hormone beta receptor (TRβ) agonist, ABX-002 has shown target engagement in regions of the brain linked with depression.

Autobahn Therapeutics research and development head and executive vice-president Gudarz Davar said: “We are encouraged by this Phase I study results, which demonstrate CNS target engagement and an overall favourable PK, safety, and tolerability profile for ABX-002. 

“Synthetic thyroid hormone treatment is well understood to offer benefit as an adjunctive treatment for MDD, however, it is not approved for use in the US and its clinical utility is limited largely due to concerns about long-term safety and monitoring.”