BioAge Announces Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor

Core Insights - BioAge Labs, Inc. announced positive interim data from the Phase 1 clinical trial of BGE-102, a novel NLRP3 inhibitor aimed at treating cardiovascular risk factors in patients with obesity [1][9] - The trial demonstrated strong target engagement with 90-98% suppression of IL-1β, indicating effective inhibition of inflammation [1][5] - BGE-102 showed high brain penetration, achieving target IC90 levels in cerebrospinal fluid, which is crucial for addressing both central and peripheral inflammation [1][5] Safety & Tolerability - BGE-102 was well tolerated across all evaluated dose levels in both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, with adverse events being infrequent and mild to moderate [5][6] - The ongoing Phase 1 study is randomized, double-blind, and placebo-controlled, involving healthy volunteers and obese participants [3] Pharmacokinetics & Pharmacodynamics - The pharmacodynamic effects were assessed using an ex vivo whole blood stimulation assay, confirming significant inhibition of IL-1β production [3][5] - In MAD cohorts, BGE-102 at doses of 60 mg and higher maintained plasma concentrations exceeding IC90 for 24 hours, with cerebrospinal fluid concentrations also surpassing IC90 after 14 days [5][6] CNS Penetration - High brain penetration is a key differentiator for BGE-102 compared to other NLRP3 inhibitors, enabling comprehensive targeting of inflammation in both the central nervous system and peripheral tissues [5][6] Phase 1 Study Design - The Phase 1 study consists of two parts: Part 1 evaluated SAD at four dose levels (10, 30, 60, and 120 mg), while Part 2 assessed MAD administered once daily for 14 days [3][4] - The MAD portion has been expanded to include obese participants with elevated hsCRP, with data expected in the first half of 2026 [4][11] Anticipated Milestones - Completion of Phase 1 MAD cohorts and initiation of a Phase 2a proof-of-concept study in patients with obesity and cardiovascular risk factors are anticipated by the first half of 2026 [11] - The Phase 2a study will enroll approximately 100 patients, focusing on changes in hsCRP and other inflammatory biomarkers [11]