BioAge Labs doses first patient in Phase 2 trial of BGE-102 for diabetic macular edema
The trial, called QUELL-DME, will test the oral NLRP3 inhibitor alone and alongside anti-VEGF therapy in about 180 participants, with topline data expected in the second half of 2027.
BioAge Labs, Inc. disclosed in an October 2, 2026 Form 8-K that the first participant has been dosed in QUELL-DME, a randomized, controlled Phase 2 trial evaluating once-daily oral BGE-102, an NLRP3 inhibitor, in adults with diabetic macular edema, and provided updates on the trial design.1
The study is designed as a randomized, controlled, three-arm trial enrolling approximately 180 participants, testing oral BGE-102 both alone and alongside anti-VEGF treatment, with dosing once a day for 12 weeks followed by a four-week follow-up period.1
Participants will be split evenly across the three arms. The three groups are intravitreal anti-VEGF paired with oral placebo, intravitreal anti-VEGF paired with 90 mg of daily BGE-102, and a sham intravitreal injection paired with 90 mg of daily BGE-102.1
The trial's main measure is visual function. The primary endpoint is change in best-corrected visual acuity at week 12, while exploratory endpoints include retinal parameters along with intraocular and plasma biomarkers.1
BioAge said topline results are expected in the second half of 2027, and the findings are expected to help shape its development approach for other retinal diseases driven by NLRP3, including geographic atrophy.1
The filing included standard forward-looking statement cautions, noting that outcomes could differ from expectations due to risks tied to clinical trial timing and results, regulatory review, and other factors outlined in the company's SEC filings, including its 10-Q filed August 5, 2026.
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