Bioage Labs Inc.
10/02/2026 | Press release | Distributed by Public on 10/02/2026 14:15
Material Event (Form 8-K)
Item 8.01 Other Events
BioAge Labs, Inc. (the "Company") recently announced 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 ("DME"), and provided updates on the QUELL-DME Phase 2 trial design.
QUELL-DME Trial Design
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Randomized, controlled, three-arm, approximately 180-participant trial evaluates oral BGE-102 as monotherapy and in combination with anti-VEGF therapy over 12 weeks of once-daily dosing, with a four-week follow-up.
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The participants are randomized 1:1:1 among the trial's three arms, which include (i) intravitreal anti-VEGF and oral placebo, (ii) intravitreal anti-VEGF and BGE-102 at 90 mg, dosed daily, and (iii) sham (simulated) intravitreal injection and BGE-102 at 90 mg, dosed daily.
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Primary endpoint is change in best-corrected visual acuity at week 12; exploratory endpoints include measures of retinal parameters and intraocular and plasma biomarkers.
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Topline results expected in the second half of 2027; the results are expected to inform the development strategy in other NLRP3-driven retinal diseases, including geographic atrophy.
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