BioAge Labs

The company is a clinical-stage biopharmaceutical organization focused on developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. Incorporated in Delaware, its technology platform and differentiated human datasets enable the identification of promising targets based on insights into molecular changes driving the aging process. The company's primary focus is on addressing metabolic disease, one of the most significant global healthcare challenges.

Azelaprag, the company's lead product candidate, is an orally available small molecule that has been well-tolerated in 265 individuals across eight Phase 1 clinical trials. In preclinical obesity models, azelaprag demonstrated the ability to more than double the weight loss induced by a glucagon-like-peptide-1 receptor (GLP-1R) agonist while also restoring healthy body composition and improving muscle function. These preclinical results are supported by a Phase 1b clinical trial in older adults on bed rest, where decreased muscle atrophy, preservation of muscle quality, and improved metabolism were observed in subjects treated with azelaprag over a 10-day period.

The company plans to evaluate azelaprag’s potential to drive significant improvements in weight loss when combined with a GLP-1R agonist in two Phase 2 clinical trials. While the results of these preclinical studies and early clinical trials demonstrate azelaprag's potential for treating metabolic disease, they may not predict outcomes in later-stage clinical trials. The ongoing STRIDES clinical trial will assess azelaprag in combination with tirzepatide, marketed as Zepbound® by Eli Lilly and Company, with topline results expected in the third quarter of 2025. A second Phase 2 clinical trial will evaluate azelaprag in combination with semaglutide, marketed as Wegovy® by Novo Nordisk, with initiation anticipated in the first half of 2025. The company believes these trials will directly support its ultimate goal of developing an all-oral combination product for obesity. Additionally, an insulin sensitivity proof-of-concept trial of azelaprag monotherapy is planned for the first half of 2025 to explore potential indication expansion.

The company is also developing orally available small molecule brain-penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. It anticipates submitting an Investigational New Drug (IND) application for an NLRP3 inhibitor in the second half of 2025 and, if cleared, initiating a Phase 1 clinical trial in the first half of 2026.

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