Core Insights - BioAge Labs, Inc. is advancing its lead product candidate BGE-102, a small-molecule NLRP3 inhibitor, targeting obesity and related metabolic diseases with an IND submission planned for mid-2025 and initial Phase 1 data expected by the end of 2025 [1][9][10] Company Overview - BioAge Labs is a clinical-stage biotechnology company focused on developing therapeutic candidates for metabolic diseases by targeting the biology of human aging [10] - The company has identified NLRP3 as a therapeutic target based on its analysis of human aging cohorts, linking reduced NLRP3 activity to greater longevity [2] Product Development - BGE-102 has shown significant weight loss in preclinical obesity models, achieving approximately 15% weight reduction as monotherapy and over 20% when combined with GLP-1 receptor agonists like semaglutide [3][4] - The compound is characterized by a novel structure with a unique binding site, high potency (2 nM IC90 in human microglia), and favorable pharmacokinetics suggesting once-daily dosing [7][6] - Preclinical studies indicate a favorable safety profile for BGE-102, with a 35–75x safety margin for the predicted human dose and no adverse effects observed in toxicology studies [8] Clinical Milestones - The company plans to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial following IND clearance, with initial SAD data anticipated by the end of 2025 [9][12] - A Phase 1b proof-of-concept study in obesity is expected to commence in the second half of 2026, contingent on successful Phase 1 results [9]
BioAge Labs completes IND-enabling studies for BGE-102, a potent, orally available, brain-penetrant NLRP3 inhibitor, and advances candidate toward the clinic