BioAge Labs Cancels STRIDES Phase 2 Trial of Azelaprag and Tirzepatide for Obesity

BioAge Labs, a clinical-stage biopharmaceutical company focusing on developing treatments for metabolic diseases through the study of human aging biology, recently decided to terminate its ongoing Phase 2 clinical trial of azelaprag. This decision followed the observation of liver transaminitis in some participants, although these elevations did not present any significant clinical symptoms.

Azelaprag was being tested both as a standalone treatment and in combination with tirzepatide. The study, known as STRIDES, involved randomizing participants into different treatment groups to evaluate the drug's efficacy and safety in reducing body weight among individuals aged 55 and older with obesity. Despite the promising preclinical and Phase 1b results of azelaprag, BioAge determined that the safety profile observed in the Phase 2 trial did not align with their standards for an optimal oral obesity therapy.

Kristen Fortney, CEO and co-founder of BioAge Labs, emphasized that patient safety is paramount in their clinical studies. Given the observed safety concerns, the company decided to halt the trial, which had enrolled 204 participants, 11 of whom experienced elevated liver transaminase levels without significant symptoms while taking azelaprag. No such elevations were seen in the tirzepatide-only group. BioAge will discontinue dosing for all subjects and cease enrolling new participants, although clinical follow-up will continue for those already enrolled.

The company plans to analyze the available data from the trial and share updated plans for azelaprag in the first quarter of 2025. Despite the setback with azelaprag, BioAge remains committed to developing therapies for metabolic aging. The company is advancing its pipeline, including a novel NLRP3 inhibitor targeting neuroinflammation linked to metabolic and neurodegenerative diseases. This inhibitor is expected to reach Investigational New Drug (IND) submission in the latter half of 2025.

BioAge is also exploring other innovative mechanisms derived from their proprietary platform, which leverages extensive molecular data on human aging. Their research focuses on creating therapeutic candidates for conditions like obesity, driven by insights into metabolic aging pathways.

BioAge Labs continues to push forward with its mission by developing brain-penetrant NLRP3 inhibitors, demonstrating high potency and unique binding sites. These efforts aim to address diseases marked by neuroinflammation. Additionally, their discovery platform, grounded in decades of human longevity data, guides the development of novel therapies targeting key pathways in metabolic aging.

The discontinuation of the azelaprag trial marks a significant yet instructive development for BioAge Labs. The company remains steadfast in its broader goal of harnessing the biology of human aging to combat metabolic diseases, ensuring that patient safety remains at the forefront of its clinical and research endeavors.