BGE-102 / BioAge Labs - LARVOL DELTA

BioAge Labs completes IND-enabling studies for BGE-102, a potent, orally available, brain-penetrant NLRP3 inhibitor, and advances candidate toward the clinic (GlobeNewswire) - "In preclinical models of obesity, BGE-102 monotherapy produced dose-dependent weight loss similar in magnitude to semaglutide, with optimal doses achieving approximately 15% weight reduction. The weight loss, driven by reduced food intake, was sustained over 28 days of treatment. BGE-102 treatments also yielded improvements in insulin sensitivity, similar in magnitude to those seen with semaglutide....BioAge plans to submit an Investigational New Drug (IND) application for BGE-102 in mid-2025. Following IND clearance, the Company expects to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial, with initial SAD data anticipated by the end of 2025. Following successful Phase 1 results, BioAge plans to initiate a Phase 1b proof-of-concept study in obesity in the second half of 2026."

IND • New P1 trial • Preclinical • Obesity

NLRP3 program development (GlobeNewswire) - "In preclinical studies, NLRP3 inhibition has demonstrated significant weight loss potential. IND-enabling studies are currently underway, with initial Phase 1 data anticipated in the second half of 2025...Research and development expenses were $11.1 million for the quarter ended March 31, 2025, compared to $9.3 million for the same period in 2024. The $1.8 million increase in research and development expenses was primarily attributable to a $2.7 million increase in direct costs related to other programs as BioAge focused its research and development activities on IND-enabling activities for BGE-102."

Commercial • P1 data • Obesity

BioAge Labs Reports Full Year 2024 Financial Results and Provides Business Updates from the Fourth Quarter of 2024 (GlobeNewswire) - "NLRP3 inhibitors: progression of BGE-102: Potential for use in an oral combination for obesity: in preclinical models, NLRP3 inhibition has demonstrated weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist....IND-enabling experiments for BGE-102 are currently underway, with Phase 1 single ascending dose (SAD) data anticipated in 2H25 and multiple ascending dose (MAD) data anticipated in 1H26."

P1 data • Preclinical • Obesity

Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025 (GlobeNewswire) - "BioAge is developing its novel, proprietary class of NLRP3 inhibitors, which have distinctive structural and biological properties and include molecules that penetrate the blood–brain barrier, for diseases associated with neuroinflammation. The Company has nominated a member of this class, the orally available, small-molecule brain-penetrant NLRP3 inhibitor BGE-102, as a development candidate. The structurally novel drug has potential best-in-class features, including high potency and high brain penetration, an important attribute for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity. IND-enabling experiments for BGE-102 are currently underway, and Phase 1 SAD data are anticipated by the end of 2025."

New molecule • P1 data • Inflammation • Obesity