BioAge Labs Discontinues Phase II Obesity Study Due to Safety Concerns, Stock Plummets

Study Discontinuation:
BioAge Labs announced the discontinuation of its Phase II STRIDES study evaluating azelaprag, an oral drug candidate for obesity treatment, due to safety concerns related to liver transaminitis observed in some participants1 2 3.

Safety Concerns:
Of the 204 subjects enrolled, 11 participants treated with azelaprag developed liver transaminitis, although none showed clinically significant symptoms. No such issues were observed in the tirzepatide-only treatment group1 2 3.

Stock Impact:
The company's stock plummeted 70% in post-market trading following the announcement, with further downgrades from analysts such as Morgan Stanley, Citi, and Jefferies1 4.

Future Plans:
BioAge Labs will continue to analyze data from enrolled subjects and share updated plans for azelaprag in the first quarter of 2025. The company also plans to advance its NLRP3 inhibitor program, with an IND submission anticipated in the second half of 20252 3 4.

Market Context:
The discontinuation of STRIDES represents a rare setback for the next-generation obesity treatment field, coming shortly after Amgen's underwhelming Phase II data for MariTide1 5.