It didn’t take long for the shine to come off one of biotech’s recent IPO success stories, with BioAge Labs scrapping a phase 2 obesity trial barely two months after going public.
The California-based company launched onto the Nasdaq in late September via a $198 million IPO, with the money earmarked for its sole clinical-stage candidate azelaprag. The orally delivered apelin receptor agonist has been undergoing a phase 2 weight loss trial in combination with Eli Lilly’s obesity med Zepbound, while a midstage study in combination with Novo Nordisk’s own approved obesity drug Wegovy was slated to begin in the first half of next year.
But, in a surprise move, BioAge revealed in a postmarket release Nov. 6 that it is halting the Zepbound study after observing liver transaminitis among 11 of the 204 subjects so far enrolled in the study. These patients did not have “clinically significant symptoms,” the biotech pointed out.
Transaminitis is a condition defined by higher than normal levels of enzymes called transaminases in the blood. Elevated levels of transaminase were not observed in the Zepbound-only cohort, BioAge noted in the release.
“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,” BioAge CEO Kristen Fortney, Ph.D., explained in the release.
“While this outcome is a significant disappointment, we remain encouraged by azelaprag’s promising preclinical and phase 1b efficacy profile,” Fortney added. “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.”
The news sent BioAge’s stock plummeting 66% in premarket trading Monday to $6.84. The biotech’s shares had ended Friday’s trading at $20.09, having held onto their value since debuting at $18 apiece in the Sept. 26 IPO.
The company said it has notified regulatory authorities, including the FDA, of its move to halt enrollment in the study and plans to share an updated plan for azelaprag in the first quarter of 2025. In the second half of next year, the company hopes to submit an IND application for its central nervous system-penetrant NLRP3 inhibitor that it's aiming at metabolic disease.