BioAge Labs has halted the Phase II randomised STRIDES trial of its investigational drug azelaprag, both as single agent and in conjunction with tirzepatide, following the observation of liver transaminitis in some patients.
No transaminase elevations were detected in the arm treated with tirzepatide alone.
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The placebo-controlled, double-blind trial, which aimed to enrol around 220 individuals aged 55 years and above with obesity, was assessing the drug’s efficacy in weight reduction and other health outcomes.
It was designed to test the safety and efficacy of the therapy at two oral doses of 300mg, once or two times- a day combined with a weekly subcutaneous injection of tirzepatide of 5mg.
Topline outcomes were expected by the fourth quarter of the next year. The trial is conducted in collaboration with Eli Lilly and Company’s Chorus clinical development organisation, where Lilly provided tirzepatide.
An azelaprag monotherapy arm was included in the trial to gather more safety data. Out of the 204 participants enrolled to date, 11 participants in the azelaprag group exhibited transaminase elevations without significant symptoms.
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By GlobalDataConsequently, dosing for all participants has been ceased, and no further enrolment will take place. However, clinical follow-up off-drug will proceed for those already enrolled.
The company has informed all trial investigators and regulatory authorities, including the US Food and Drug Administration (FDA), of its decision. Further updates on azelaprag are expected in the first quarter of next year.
BioAge CEO and co-founder Kristen Fortney said: “We made the difficult decision to discontinue the STRIDES Phase II study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy.
“While this outcome is a significant disappointment, we remain encouraged by azelaprag’s promising preclinical and PhIb efficacy profile.
“In parallel to assessing the next steps for the azelaprag programme, we will continue to advance our NLRP3 inhibitor programme as well as additional research programmes with novel mechanisms emerging from our platform.”
Despite this setback, the company continues to progress its pipeline, focusing on the biology of aging to address metabolic diseases.
In October 2023, the company announced the plan for a Phase II trial of BGE-105 (azelaprag), with tirzepatide combination to treat obesity.
