BioAge Labs is to discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag as monotherapy and in combination with tirzepatide after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag. No transaminase elevations were observed in the tirzepatide only treatment group.
STRIDES is a randomised, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enrol approximately 220 individuals with obesity aged 55 years and older. The trial was designed to evaluate the efficacy as measured by body weight reduction and other outcomes, safety, and tolerability of two oral doses of azelaprag (300mg, once or twice daily) in combination with tirzepatide (5mg subcutaneous injection once weekly). An azelaprag monotherapy arm was included to provide additional safety information.
Of 204 subjects enrolled in STRIDES as of today, 11 subjects in the azelaprag treatment groups were observed to have transaminase elevations with no clinically significant symptoms. Dosing of all subjects will be discontinued and no additional subjects will be enrolled. Clinical follow-up of enrolled subjects will continue off drug.
“Patient safety is our top priority in the conduct of our clinical studies,” said Dr Kristen Fortney, CEO and co-founder of BioAge. “We made the difficult decision to discontinue the STRIDES Phase 2 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 Ph1b efficacy profile. We remain committed to our focus on developing therapies for metabolic aging. In parallel to assessing the next steps for the azelaprag programme, we will continue to advance our NLRP3 inhibitor program as well as additional research programs with novel mechanisms emerging from our platform.”
The company intends to further analyse available STRIDES clinical data from all enrolled subjects and it has notified all study investigators and regulatory authorities including the FDA of its decision to discontinue enrolment.
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