BioAge shares tumble after decision to halt obesity drug study

Dive Brief:

• BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with Eli Lilly’s tirzepatide due to safety concerns, causing its share price to slide by three-quarters in after-hours trading Friday.
• Eleven people who received azelaprag in STRIDES, BioAge’s Phase 2 study, showed elevated levels of liver enzymes that can warn of potential organ damage. As a result, the company is discontinuing dosing and halting further enrollment.
• The San Francisco Bay Area company raised $170 million in February and banked a $198 million initial public offering in September to fund its ambitious foray into metabolic drugs, not long after it pivoted from making treatments for age-related diseases.

Dive Insight:

Study researchers spotted the spike in liver enzymes, or liver transaminitis, among people who received BioAge’s drug either as monotherapy or in combination with tirzepatide, which Lilly sells as Zepbound. No participants who were treated only with Zepbound experienced liver transaminitis.

The increase in enzyme counts was not associated with any clinically significant symptoms, BioAge said. The company plans to share an update in early 2025 on its plans for azelaprag’s development.

“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,” Kristen Fortney, BioAge’s CEO, said in a statement.

Azelaprag is designed to mimic a peptide called apelin, which is excreted in response to physical exercise. Preclinical data from BioAge seemed to show that combining azelaprag with incretin drugs could boost the effects of the latter, helping patients shed weight but preserve muscle.

The company launched the study, which was set to enroll 220 people with obesity ages 55 and older, in July. At the time, Fortney said the drug could be “a powerful pharmacological parallel to the exercise and diet interventions that form the foundation of obesity management.”

BioAge had originally planned to launch a Phase 2 clinical trial with semaglutide, or Novo Nordisk’s Wegovy, in the first half of 2025.

With azelaprag, BioAge was targeting a niche that venture investors and pharmaceutical companies alike have been trying to fill as Wegovy and Zepbound have gained popularity: preserving lean muscle mass while still shedding weight. The company licensed azelaprag from Amgen in 2021 with plans to develop it to combat muscle aging.

Over the past two years, several companies have shared plans to make experimental weight loss drugs designed to do the same thing, including Scholar Rock, Biohaven Pharmaceutical and Regeneron. Venture investors have also bought in, backing early startups such as SixPeaks Bio.

Shares in BioAge, which closed Friday at just over $20 apiece, plunged by two-thirds in post-market trading Friday.

The company plans to file an application to advance another program it’s developing for central nervous system targets in the second half of 2025.

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