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BioAge Labs Announces First Participant Dosed in QUELL-CV, a Phase 2 Proof-of-Concept Trial of BGE-102, a Novel Oral NLRP3 Inhibitor, in Patients at Elevated Cardiovascular Risk

  • BioAge Labs initiated the first participant dosing in the QUELL-CV Phase 2 proof-of-concept trial for BGE-102, a novel oral NLRP3 inhibitor.
  • The randomized, double-blind, placebo-controlled trial evaluates three once-daily oral doses (30 mg, 60 mg, 90 mg) against placebo in approximately 160 adults with obesity, elevated hsCRP (>3 mg/L), & additional cardiovascular risk factors.
  • The primary endpoint is the percent change from baseline in high-sensitivity C-reactive protein (hsCRP) to support optimal dose selection for Phase 3.
  • Topline data from the 12-week dosing period are anticipated in the second half of 2026.
  • Previous Phase 1 results indicated BGE-102 achieved up to 86% median hsCRP reduction & was well-tolerated across all dose levels.
  • BioAge plans to start a Phase 1b/2a trial for diabetic macular edema in mid-2026, with results expected by mid-2027.
  • BGE-102 is being developed as a once-daily oral therapy targeting cardiovascular risk reduction & retinal diseases driven by NLRP3 inflammation.