BioAge Sets Mid-2026 Phase 1b/2a DME Trial for Oral NLRP3 Inhibitor with Parallel 2H26 Cardiovascular Study
BioAge will initiate a Phase 1b/2a proof-of-concept trial in diabetic macular edema patients in mid-2026, evaluating oral NLRP3 inhibitor BGE-102’s target engagement via intraocular IL-6 reduction and exploratory BCVA and CST endpoints. This DME study runs alongside a cardiovascular Phase 2a trial with results expected in 2H 2026 and DME data mid-2027.
1. BioAge Launches $75 Million Underwritten Offering
BioAge Labs has filed for an underwritten public offering to sell up to $75.0 million of its common stock, with a 30-day option for underwriters to acquire an additional $11.25 million of shares. Goldman Sachs & Co. LLC, Piper Sandler and Citigroup will serve as joint book-running managers. The company plans to use net proceeds, together with existing cash, cash equivalents and marketable securities, to advance research and clinical and process development of its lead candidate BGE-102, to expand its NLRP3 and APJ programs, to fund manufacturing, working capital and capital expenditures, and to reduce indebtedness. The offering is being conducted under a Form S-3 registration statement effective November 25, 2025, with a preliminary prospectus supplement to be filed with the SEC. Completion of the offering is subject to market and other customary conditions.
2. Oral NLRP3 Inhibitor BGE-102 Poised for Ophthalmology Trial
BioAge is extending BGE-102’s development into diabetic macular edema (DME), planning a Phase 1b/2a proof-of-concept trial in mid-2026. In ongoing Phase 1 SAD/MAD cohorts, BGE-102—an orally available, brain-penetrant NLRP3 inhibitor—has shown favorable tolerability and robust biomarker reductions: up to 65% declines in hsCRP and 55% in IL-6 at steady state in obese participants. Preclinical studies demonstrated dose-dependent retinal vascular protection with near-complete prevention of vascular leakage and 90% microvascular integrity preservation in DME models, and an 80% reduction in lipofuscin accumulation in aging retina models. The randomized, controlled DME trial will assess monotherapy and combination with a VEGF inhibitor across three arms, with primary endpoint of percent change in intraocular IL-6; exploratory endpoints include best-corrected visual acuity and central subfield thickness. DME results are expected mid-2027, running parallel to BGE-102’s Phase 2a cardiovascular risk trial due in 2H 2026.