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BioAge Labs Announces First Participant Dosed in QUELL-DME, a Phase 2 Trial of BGE-102, a Novel Oral NLRP3 Inhibitor, in Diabetic Macular Edema

BIOA
  • BioAge Labs has dosed the first participant in QUELL-DME, a randomized, controlled Phase 2 trial for diabetic macular edema (DME).
  • The approximately 180-participant study evaluates oral BGE-102 as monotherapy and in combination with standard-of-care anti-VEGF therapy.
  • BGE-102 is a once-daily, orally available NLRP3 inhibitor designed to target inflammation upstream of vascular leakage.
  • The trial's primary endpoint is the change in best-corrected visual acuity at week 12.
  • The trial design includes three arms: anti-VEGF plus oral placebo, anti-VEGF plus BGE-102 (90 mg QD), and sham injection plus BGE-102 (90 mg QD).
  • Topline results from the QUELL-DME trial are expected in the second half of 2027.
  • Findings will inform development strategies for other NLRP3-driven retinal diseases, including geographic atrophy.
  • BioAge's concurrent Phase 2 obesity trial, QUELL-CV, has completed enrollment with topline data anticipated in the second half of 2026.