BioAge Labs has dosed the first participant in QUELL-DME, a phase 2 trial evaluating the investigational oral NLRP3 inhibitor BGE-102 in patients with diabetic macular edema (DME).

The randomized, controlled trial is expected to enroll approximately 180 adults, who will be assigned 1:1:1 to intravitreal anti-VEGF therapy plus oral placebo, anti-VEGF therapy plus BGE-102 90 mg once daily, or a simulated intravitreal injection plus BGE-102 90 mg once daily. Oral treatment will continue for 12 weeks, followed by 4 weeks of follow-up.

The primary endpoint is change from baseline in best-corrected visual acuity at week 12. Exploratory endpoints include retinal measures and intraocular and plasma biomarkers. Topline results are expected in the second half of 2027.

BGE-102 is a small-molecule inhibitor of NLRP3, an inflammasome implicated in inflammatory signaling, VEGF production, and blood-retinal barrier disruption. The study is designed to assess BGE-102 both as monotherapy and as an adjunct to anti-VEGF treatment.

The drug previously completed a phase 1 single- and multiple-ascending-dose study. BioAge is also evaluating BGE-102 in a phase 2 study in patients with obesity and elevated systemic inflammation. RP