Announcement • Sep 08

BioAge Labs Doses First Participant In QUELL-DME Phase 2 Trial Of BGE-102 In Diabetic Macular Edema

BioAge Labs, Inc. announced that the first participant has been dosed in QUELL-DME, a randomized, controlled Phase 2 trial evaluating once-daily oral BGE-102 in adults with diabetic macular edema (DME). The approximately 180-participant study will evaluate BGE-102 both as monotherapy and in combination with standard-of-care anti-VEGF therapy, with change in best-corrected visual acuity at week 12 as the primary endpoint. BGE-102 is a structurally novel, once-daily oral NLRP3 inhibitor. QUELL-DME is a randomized, controlled, three-arm Phase 2 trial evaluating oral BGE-102 in patients with diabetic macular edema, both as monotherapy and as an add-on to standard-of-care anti-VEGF intravitreal therapy. Population: Approximately 180 adults with diabetic macular edema, randomized 1:1:1. Arms: Intravitreal anti-VEGF + oral placebo, intravitreal anti-VEGF + BGE-102 90 mg QD, sham (simulated) intravitreal injection + BGE-102 90 mg QD. Duration: 12 weeks of once-daily oral dosing, with 4-week follow-up. Primary endpoint: Change from baseline in best-corrected visual acuity (BCVA) at week 12. Exploratory endpoints: Measures of retinal parameters and intraocular and plasma biomarkers. Topline results are anticipated in the second half of 2027. BGE-102 is a structurally novel, potent, orally available, brain-penetrant small molecule NLRP3 inhibitor discovered by BioAge. NLRP3 is a central driver of age-related chronic inflammation that has been implicated in cardiovascular disease, metabolic disorders including obesity, and neurodegenerative conditions. NLRP3 activation has also been identified as a central feature of multiple inflammation-driven retinal diseases, including diabetic macular edema and geographic atrophy. BioAge's discovery platform identified NLRP3 as a therapeutic target based on analysis of human aging cohorts, which revealed that reduced NLRP3 activity is associated with greater longevity. BioAge is also conducting QUELL-CV, a Phase 2 dose-ranging trial evaluating BGE-102 in patients with obesity and elevated baseline inflammation; QUELL-CV has completed enrollment, and topline data are anticipated in the second half of 2026. In a Phase 1 SAD/MAD trial in healthy volunteers and participants with obesity and elevated systemic inflammation, BGE-102 demonstrated potential best-in-class reductions in hsCRP and other inflammatory biomarkers. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers. Phase 2 cardiovascular proof-of-concept data from QUELL-CV are anticipated in the second half of 2026, and Phase 2 diabetic macular edema data from QUELL-DME are anticipated in the second half of 2027.

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