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BioAge Labs Announces Discontinuation of STRIDES Phase 2 Clinical Trial Evaluating Azelaprag in Combination with Tirzepatide for the Treatment of Obesity
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from
About this update from Bioage Labs, Inc.
[{"type":"text","content":"Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025 In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of 2025 RICHMOND, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- BioAge Labs (Nasdaq: BIOA) (“BioAge”, “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company has made the decision 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. “Patient safety is our top priority in the conduct of our clinical studies,” said Kristen Fortney, PhD, 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 program, we will continue to advance our NLRP3 inhibitor program as well as additional research programs with novel mechanisms emerging from our platform.” STRIDES is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enroll approximately 220 individuals with obesity aged 55 years and older (link). 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 (300 mg, once or twice daily) in combination with tirzepatide (5 mg s...