BioAge Labs, a clinical-stage biopharmaceutical company, announced it will discontinue the Phase 2 STRIDES clinical trial evaluating azelaprag, both as a monotherapy and in combination with tirzepatide, due to the observation of liver transaminitis in some participants. The company is now prioritizing its NLRP3 inhibitor program and expanding discovery efforts through collaborations with Novartis and Lilly. The decision to halt the azelaprag trial underscores BioAge's commitment to patient safety and strategic pipeline management.
Azelaprag Development Halted Due to Liver Transaminitis
The STRIDES trial, a randomized, double-blind, placebo-controlled Phase 2 study, aimed to enroll approximately 220 individuals with obesity aged 55 years and older. It was designed to assess the efficacy, safety, and tolerability of azelaprag, an orally available small molecule agonist of APJ, in combination with tirzepatide. However, during the trial, 11 out of 204 subjects in the azelaprag treatment groups showed transaminase elevations, prompting the company to halt the study. No transaminase elevations were observed in the tirzepatide-only treatment group.
"Patient safety is our top priority in the conduct of our clinical studies," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "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."
Advancing NLRP3 Inhibitor Program
With the azelaprag program facing challenges, BioAge is now focusing on its novel class of brain-penetrant NLRP3 inhibitors. The lead candidate, BGE-102, is an orally available, small-molecule brain-penetrant NLRP3 inhibitor with potential best-in-class features, including high potency and high brain penetration. IND-enabling experiments for BGE-102 are currently underway, and Phase 1 SAD data are anticipated by the end of 2025. The NLRP3 inhibitor program targets neuroinflammation, which is linked to both metabolic and neurodegenerative diseases.
Expanding Discovery Efforts Through Collaborations
BioAge continues to leverage its discovery platform, which analyzes longitudinal human aging data to reveal key molecular drivers of healthy aging. In December, BioAge announced a multi-year research collaboration with Novartis to identify and validate novel therapeutic targets at the intersection of aging biology and exercise. Under the terms of the agreement, BioAge will receive up to $20 million in upfront payments and research funding, plus up to $530 million in future long-term research, development, and commercial milestones.
BioAge has also entered a strategic collaboration with Lilly ExploR&D to discover two therapeutic antibodies that address novel metabolic aging targets identified by BioAge's discovery platform.
Strong Financial Position
As of September 30, 2024, BioAge had approximately $334.5 million in cash and cash equivalents. This amount is not inclusive of the additional $27.6 million net fees from the exercise of the IPO's greenshoe option on October 1, 2024. Existing cash and cash equivalents extend cash runway beyond 2029.
