BioAge Doses First Participant in Phase 2 BGE-102 Trial Testing 30–90 mg
BIOA•BioAge has dosed the first participant in its randomized Phase 2 QUELL-CV trial evaluating 30 mg, 60 mg and 90 mg once-daily BGE-102 in 160 adults with hsCRP above 3 mg/L and cardiovascular risk factors. Results are expected late 2026, with a diabetic macular edema proof-of-concept trial starting mid-2026.
1. Phase 2 QUELL-CV Trial Launch
BioAge has initiated QUELL-CV, a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial enrolling approximately 160 adults with obesity, hsCRP >3 mg/L and additional cardiovascular risk factors. Participants are randomized to placebo or BGE-102 at 30 mg, 60 mg or 90 mg once daily for 12 weeks, with percent change in hsCRP as the primary endpoint.
2. Phase 1 Efficacy and Safety
In a completed Phase 1 single and multiple ascending dose trial, BGE-102 achieved median hsCRP reductions of 86% at both 60 mg and 120 mg once-daily doses, with 87–93% of treated participants normalizing hsCRP (<2 mg/L). The inhibitor was well tolerated with no serious adverse events, no discontinuations and stable vital signs, ECGs and laboratory values.
3. Development Timeline
Topline QUELL-CV results are anticipated in the second half of 2026 to guide Phase 3 dose selection. A second proof-of-concept study in diabetic macular edema is slated to start mid-2026, with data expected in mid-2027.
4. BGE-102 Mechanism and Pipeline
BGE-102 is an orally available, brain-penetrant small-molecule NLRP3 inhibitor targeting chronic inflammation linked to cardiovascular, metabolic and retinal diseases. BioAge’s discovery platform selected NLRP3 based on human aging data, and the company is also advancing long-acting APJ agonists for obesity and other preclinical candidates.
