BGE-102 - (QUELL-DME)

September 8, 2026: BioAge Labs (NASDAQ: BIOA) announced first-patient dosed in QUELL-DME, a randomized, controlled Phase 2 trial of once-daily oral NLRP3 inhibitor BGE-102 in adults with diabetic macular edema. The approximately 180-patient, three-arm study is evaluating BGE-102 90 mg as monotherapy and with standard-of-care intravitreal anti-VEGF versus anti-VEGF plus oral placebo. The primary endpoint is change from baseline in best-corrected visual acuity at week 12; exploratory endpoints include retinal measures and intraocular/plasma biomarkers. Topline QUELL-DME results are expected in the second half of 2027. The company said the outcome will also help guide development in other NLRP3-driven retinal diseases, including geographic atrophy.

Also for BGE-102, BioAge said QUELL-CV, a Phase 2 dose-ranging trial in patients with obesity and elevated baseline inflammation, has completed enrollment, with topline data expected in the second half of 2026. The release also notes BGE-102 has completed a Phase 1 SAD/MAD trial in healthy volunteers and participants with obesity and elevated systemic inflammation, where it showed reductions in hsCRP and other inflammatory biomarkers and was described as well tolerated.