BGE-102

June 16, 2026: BioAge Labs, Inc. (NASDAQ: BIOA) announced first patient dosed in QUELL-CV, a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 proof-of-concept trial of BGE-102, an oral once-daily small-molecule NLRP3 inhibitor being developed for cardiovascular risk reduction.

QUELL-CV will enroll ~160 adults with obesity, elevated systemic inflammation (hsCRP >3 mg/L), and at least one additional cardiovascular risk factor. Participants are randomized (n=40/arm) to placebo or BGE-102 30 mg, 60 mg, or 90 mg QD for 12 weeks. The primary endpoint is percent change from baseline in hsCRP; additional endpoints include hsCRP normalization (<2 mg/L) and other inflammatory, cardiometabolic, and imaging biomarkers. Topline data are expected in the second half of 2026 (also referenced as by end of 2026).

The release also summarizes prior Phase 1 SAD/MAD results: median hsCRP reductions of 86% at 60 mg and 120 mg QD, with 87–93% achieving hsCRP normalization; IL-6 and fibrinogen reductions; ≥90% IL-1β suppression at trough ex vivo; CSF exposure at/above IC90; and favorable tolerability with no serious AEs or discontinuations.

BioAge plans to start a Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema in mid-2026, with results anticipated mid-2027.