BioAge Labs, a recent success in the biotechnology IPO market, has made a surprising decision to discontinue its phase 2 obesity study, just weeks after its September Nasdaq debut.
The California-based biotech company raised $198 million during its initial public offering, with funds earmarked for its sole clinical-stage candidate, azelaprag. This orally administered apelin receptor activator was being tested in a phase 2 weight-loss trial in combination with Zepbound, an obesity medication from Eli Lilly. A separate midstage study combining azelaprag with Wegovy, Novo Nordisk’s obesity treatment, was slated to begin in the first half of 2025.
However, on November 6, BioAge announced via a postmarket press release that it would discontinue the Zepbound trial. The decision followed the detection of liver transaminitis in 11 out of 204 participants enrolled in the study. Despite this finding, the company noted that none of the affected individuals exhibited “clinically significant symptoms.”
Transaminitis refers to elevated levels of transaminase enzymes in the bloodstream, a potential marker of liver stress or damage. Notably, BioAge stated that the group receiving Zepbound alone did not show elevated transaminase levels.
“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,” said Kristen Fortney, Ph.D., BioAge’s CEO, in the announcement.
While expressing disappointment over the study’s outcome, Fortney emphasized the promising results azelaprag had demonstrated in preclinical and phase 1b efficacy trials. She reaffirmed BioAge’s commitment to developing therapies that address metabolic aging and highlighted the company’s continued focus on advancing its NLRP3 inhibitor program and other innovative research initiatives derived from its platform.
The announcement triggered a sharp drop in BioAge’s stock price, which fell by 66% in premarket trading on Monday, landing at $6.84. This marked a significant decline from the IPO price of $18 per share on September 26 and the closing price of $20.09 on the previous Friday.
BioAge has notified the Food and Drug Administration (FDA) and other regulatory authorities of its decision to halt participant enrollment in the trial. The company plans to present an updated strategy for azelaprag in the first quarter of 2025. Additionally, BioAge aims to submit an investigational new drug (IND) application in the second half of 2025 for its central nervous system-penetrant NLRP3 antagonist, targeting metabolic disorders.
