BioAge to Begin Mid-2026 Trial of Oral NLRP3 Inhibitor in Diabetic Macular Edema
BioAge Labs will expand clinical development of its oral brain-penetrant small molecule NLRP3 inhibitor, BGE-102, into ophthalmology, initiating a Phase 1b/2a proof-of-concept trial in patients with diabetic macular edema (DME) by mid-2026. The study is designed to assess ocular target engagement and reduction of inflammatory biomarkers, with data expected in mid-2027.
Diabetic macular edema (DME) is a complication of diabetes in which elevated blood sugar levels damage retinal blood vessels, leading to fluid leakage and swelling in the macula, the part of the retina responsible for sharp central vision. This can result in blurred or distorted vision and, in advanced cases, central vision loss or blindness. DME is a major cause of vision impairment in people with diabetes.
The oral agent, BGE-102, is being developed as a potential alternative to frequent intravitreal injections currently used in treating retinal diseases. In preclinical DME models, the drug preserved retinal vascular integrity and reduced vascular leakage. In prior studies (1, 2) NLRP3 inhibition has also shown protection of retinal pigment epithelium and reduction of lipofuscin accumulation, a hallmark of age-related retinal degeneration.
The planned three-arm trial will evaluate BGE-102 both as monotherapy and in combination with anti-VEGF treatment. The primary endpoint is lowering the levels of IL-6, a key inflammation marker, inside the eye; secondary measures include visual acuity and retinal thickness. BioAge aims to develop BGE-102 as a single oral drug that could help treat inflammation-related cardiovascular, CNS, and ocular diseases.
The DME program will run in parallel with BioAge's cardiovascular risk development for BGE-102, where a separate Phase 2a readout is expected in 2H26. BioAge aims to complete its ongoing Phase 1 study—including two additional MAD cohorts in obese individuals with elevated hsCRP—by the first half of 2026. In the ongoing Phase 1 trial, BGE-102 has already shown a good safety profile and strong reductions in key inflammation markers in participants with obesity and increased risk of cardiovascular disease.
BioAge Labs is also engaged in a multi-year collaboration with Novartis, valued at over $500 million, to discover and validate drug targets for aging-related diseases by combining 50 years of longitudinal human aging data with machine learning to identify drivers of healthy lifespan and uncover therapeutic targets. In September 2024, BioAge Labs raised nearly $200 million through a Nasdaq IPO to support clinical development of its pipeline.
Topic: NeuroTech
