BioAge Labs, Inc. (NASDAQ: BIOA) has halted its Phase 2 clinical trial of azelaprag, an investigational drug intended for the treatment of metabolic diseases such as obesity, due to safety concerns. The announcement, made in December 2024, has led to a significant drop in the company's stock price and prompted investigations into the propriety of BioAge's disclosures prior to its initial public offering (IPO) in September 2024.
The STRIDES trial was evaluating azelaprag, an oral apelin receptor agonist licensed from Amgen, both as a monotherapy and in combination with tirzepatide (Eli Lilly and Co.'s Zepbound) in patients with obesity. However, the study was discontinued after elevated levels of liver enzymes, or liver transaminitis, were observed in patients receiving azelaprag.
Safety Concerns and Trial Discontinuation
According to BioAge, eleven participants in the STRIDES trial showed elevated levels of liver enzymes, indicative of potential liver damage. While the company stated that the increase in enzyme counts was not associated with any clinically significant symptoms, the decision was made to discontinue dosing and halt further enrollment in the trial.
"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, BioAge’s CEO.
Investor Scrutiny and Legal Action
The abrupt halt of the azelaprag trial, just months after BioAge's IPO, has raised concerns among investors and led to a formal investigation by Hagens Berman, a global plaintiffs’ rights complex litigation firm. The investigation focuses on whether BioAge was transparent about the azelaprag safety profile before the December 6 announcement.
"We’re focused on whether BioAge was transparent to investors about the azelaprag safety profile before the December 6 announcement," said Reed Kathrein, the Hagens Berman partner leading the investigation.
Furthermore, BioAge is now facing a securities class action lawsuit on behalf of investors who purchased shares in the company's IPO. The lawsuit alleges that BioAge misled investors about the safety and prospects of azelaprag, presenting a picture of the STRIDES trial free of safety concerns and confidently predicting positive results. The suit claims that offering documents for BioAge's IPO contained "materially false and/or misleading" statements.
Future Plans for BioAge
Despite the setback with azelaprag, BioAge is moving forward with other programs in its pipeline. The company plans to share an update in early 2025 on its plans for azelaprag's development. BioAge is also working on newer, "structurally distinct" drugs aimed at azelaprag’s target and plans to nominate one for development next year. Additionally, the company expects to start human testing this year of a drug designed to treat diseases associated with neuroinflammation and will file an IND for its internally discovered NLRP3 inhibitors by the end of this year and move into the clinic.
"NLRP3 is an immune and brain aging target strongly linked to human longevity in our human data," said Fortney. "It's a target that shows promise in many different indications, from metabolic aging to brain aging."
