BioAge Labs has dosed the first participant in QUELL-DME, a Phase 2 trial evaluating its investigational oral NLRP3 inhibitor, BGE-102, in adults with diabetic macular edema (DME).
The randomized, controlled study is expected to enroll approximately 180 participants and will assess BGE-102 both as monotherapy and in combination with standard-of-care anti-VEGF therapy. The primary endpoint is change from baseline in best-corrected visual acuity (BCVA) at week 12. Topline results are expected in the second half of 2027.
QUELL-DME will randomize participants 1:1:1 to one of three treatment groups: intravitreal anti-VEGF plus oral placebo; intravitreal anti-VEGF plus BGE-102 90 mg once daily; or a sham intravitreal injection plus BGE-102 90 mg once daily. Participants will receive 12 weeks of oral treatment followed by four weeks of follow-up. Exploratory endpoints will include retinal parameters and intraocular and plasma biomarkers.
BGE-102 is a structurally novel, orally available small-molecule inhibitor of the NLRP3 inflammasome. NLRP3 activation has been implicated in inflammatory processes associated with DME, including IL-1β and IL-18 release, pyroptosis, VEGF production, and disruption of the blood-retinal barrier. BioAge is investigating whether systemic inhibition of the pathway could address both retinal inflammation and the wider inflammatory environment associated with diabetes.
“NLRP3 is a compelling target in DME because it sits upstream of the inflammation that drives vascular leakage and vision loss,” said Kristen Fortney, CEO and co-founder of BioAge Labs. She added that the study is designed to determine whether once-daily oral BGE-102 can improve vision while potentially offering an alternative or adjunct to repeated intravitreal injections.
“Dosing the first participant marks an important milestone for the program,” Fortney added, saying that the results will help to guide future development of other NLRP3-driven retinal diseases.
BGE-102 has previously completed a Phase 1 single- and multiple-ascending-dose study, in which BioAge reported a well-tolerated profile and reductions in inflammatory biomarkers. The drug is also being evaluated in a separate Phase 2 cardiovascular study.
Source: GlobeNewswire.
