The discontinuation of STRIDES is a rare stumble for the next-generation obesity field and comes just weeks after Amgen announced underwhelming mid-stage data for MariTide.
BioAge Labs on Friday announced that it is discontinuing the Phase II STRIDES study of its oral drug candidate azelaprag in obesity following safety concerns.
According to the California laboratory, of the 204 patients in the study, 11 participants treated with azelaprag developed liver transaminitis—though none showed clinically significant symptoms. None of the patients who were on tirzepatide alone saw similar increases in liver transaminase enzyme levels. BioAge will cease dosing all patients in STRIDES and will no longer enroll additional study participants.
CEO Kristen Fortney said in a statement that the decision to terminate STRIDES was “difficult” and a “significant disappointment,” nevertheless emphasizing that “patient safety is our top priority.” BioAge remains confident in azelaprag and will continue to analyze the findings from STRIDES, according to the company’s announcement. The biotech expects to disclose its updated plans for the candidate in the first quarter of 2025.
BioAge fell 70% in post-market trading on Friday, according to Seeking Alpha.
Designed to be administered orally, azelaprag is a small molecule drug candidate that works by mimicking the peptide apelin, which the body secretes in response to exercise. Through this mechanism of action, azelaprag activates the apelin receptor, in turn eliciting the various health benefits of exercise. According to BioAge’s website, when combined with incretin therapies, azelaprag “has the potential for best-in-class oral performance” for obesity.
The biotech sought to bear this mechanism out in STRIDES, a mid-stage, randomized, double-blinded and placebo-controlled trial that evaluated the efficacy and safety of azelaprag—with and without Eli Lilly’s blockbuster incretin treatment tirzepatide—in more than 200 individuals with obesity. Azelaprag was given at a 300-mg dose either once or twice daily. Following Friday’s discontinuation, STRIDES will continue to follow patients off-therapy, according to BioAge’s announcement.
Friday’s mid-stage disappointment comes after BioAge in February revealed that it had raised $170 million in its Series D fundraising round—money that the biotech at the time said will be used to support azelaprag’s mid-stage development. A few months later, in September, the California biotech revealed plans to debut on Nasdaq with its $198 million Initial Public Offering.
The discontinuation of STRIDES also represents a rare stumble for the next-generation obesity space and comes on the heels of Amgen’s underwhelming Phase II data for its highly anticipated bispecific molecule MariTide. Late last month, the pharma showed that MariTide could reduce body weight by around 20%—an efficacy outcome that met investors’ expectations, but only just.
“Bulls will be a little disappointed today, while bears will say Amgen is no longer a major player here to be concerned on,” according to a Jefferies note at the time.
