BioAge Labs doses first participant in Phase 2 NLRP3 trial QUELL-CV
BioAge Labs has dosed the first participant in QUELL-CV, a Phase 2 proof-of-concept study of BGE-102, its oral NLRP3 inhibitor, in adults at elevated cardiovascular risk. The Emeryville, California-based company said the trial is designed to inform dose selection for a subsequent Phase 3 programme, with topline data anticipated before year end.
QUELL-CV is a randomised, double-blind, placebo-controlled, dose-ranging study enrolling approximately 160 adults with obesity, a high-sensitivity C-reactive protein level above 3 mg/L, and at least one additional cardiovascular risk factor. Participants are randomised equally across four arms: placebo and BGE-102 at 30 mg, 60 mg, or 90 mg once daily, each taken orally for 12 weeks. The primary endpoint is the percentage change from baseline in hsCRP, with secondary measures including the proportion of participants achieving hsCRP normalisation below 2 mg/L, alongside broader inflammatory, cardiometabolic, and imaging biomarkers.
Phase 1 data and mechanistic rationale
BioAge reported Phase 1 single- and multiple-ascending-dose results earlier in 2026, in which BGE-102 achieved median hsCRP reductions of 86% at both the 60 mg and 120 mg once-daily doses in participants with obesity and elevated inflammation. Between 87% and 93% of participants on active treatment achieved hsCRP normalisation. The drug also reduced IL-6 and fibrinogen, two additional markers linked to atherothrombotic risk. No serious adverse events were reported, and no participants discontinued due to treatment-related adverse events.
NLRP3 is an inflammasome component that drives chronic low-grade inflammation associated with ageing, cardiovascular disease, and metabolic dysfunction. Inhibiting it orally is considered a meaningful challenge; a number of earlier investigational compounds have struggled with selectivity or bioavailability. BioAge's compound is also described as brain-penetrant, a property the company says is supported by cerebrospinal fluid exposure at or above the IC90 threshold for IL-1beta inhibition, though the clinical significance of CNS penetration for a cardiovascular indication remains to be established.
Chief medical officer Paul Rubin said the trial is designed to characterise the dose-response relationship across three oral dose levels and to assess effects on an expanded set of inflammatory and metabolic biomarkers, noting that hsCRP is among the most predictive biomarkers of cardiovascular risk.
Competitive landscape and broader programme
The NLRP3 inhibitor field has attracted significant interest from both large pharmaceutical companies and specialist biotechs. Novartis's canakinumab, an injectable anti-IL-1beta antibody, demonstrated cardiovascular event reduction in the CANTOS trial but never achieved commercial traction partly due to its injectable format and infection risk. An oral agent showing comparable inflammation reduction could address a gap that canakinumab could not fill, though QUELL-CV is a biomarker-driven proof-of-concept study and cardiovascular event reduction would require a substantially larger and longer outcomes trial.
Beyond QUELL-CV, BioAge plans to initiate a Phase 1b/2a study of BGE-102 in diabetic macular edema around mid-2026, with results anticipated in mid-2027. NLRP3 activation has been identified as a driver of several inflammation-related retinal conditions, and a positive signal in that indication would expand the compound's commercial addressable market considerably.
CEO Kristen Fortney said she believes an oral therapy addressing cardiovascular inflammation could replicate the impact statins had on lipid management, though that comparison carries significant commercial ambition that the Phase 2 data will need to begin substantiating. The company's stock trades on Nasdaq under the ticker BIOA.