BioAge Announces Indication Expansion for Oral NLRP3 Inhibitor BGE-102, with Plans to Initiate Phase 1b/2a Proof-of-Concept Clinical Trial in Patients with Diabetic Macular Edema in Mid-2026

Core Insights - BioAge Labs, Inc. is expanding its BGE-102 development program into ophthalmology, specifically targeting diabetic macular edema (DME) as the initial proof-of-concept indication for its orally administered NLRP3 inhibitor [1][11] - BGE-102 has shown favorable tolerability in ongoing Phase 1 trials, with significant reductions in inflammatory biomarkers such as hsCRP, IL-6, and IL-1β, indicating its potential for broader anti-inflammatory benefits [1][3][10] - The company plans to initiate a Phase 1b/2a proof-of-concept trial in DME patients in mid-2026, with results expected in mid-2027, aiming to demonstrate target engagement and pharmacodynamics [6][7][13] Development Program - BGE-102 is a potent, orally available small molecule NLRP3 inhibitor, which has shown promise in preclinical models for preserving retinal vascular integrity and reducing age-related inflammatory markers [4][10] - The drug's mechanism targets the NLRP3 inflammasome, which is implicated in various retinal diseases, including DME and geographic atrophy, suggesting potential for expansion into additional indications [2][10] - The upcoming DME trial will run in parallel with a Phase 2a cardiovascular risk trial, with results for the latter anticipated in the second half of 2026 [1][13] Clinical Evidence - Clinical data supports the targeting of inflammation in retinal diseases, with injectable IL-6 inhibitors showing sustained visual acuity gains in patients with macular edema [5] - The primary endpoint for the DME trial will be the percent change in intraocular IL-6, with additional exploratory endpoints including best-corrected visual acuity and central subfield thickness [7] Anticipated Milestones - Key milestones include the completion of the Phase 1 trial with full data readout in the first half of 2026, initiation of the DME trial in mid-2026, and data readouts for both trials expected in mid-2027 [13]