BGE-102 delivers 93% IL-1β suppression, 86% CRP reduction; cardiovascular and DME trials ahead
BGE-102 achieved 24-hour IC90 coverage at 60 mg, produced ~93% IL-1β suppression and ~86% hs-CRP plus ~50% IL-6 reductions in obese participants, with mild-to-moderate adverse events and 40- to 90-fold safety margins. BioAge plans a H2, three-month, 50-patient cardiovascular study and a three-arm diabetic macular edema trial with oral BGE-102.
1. Phase 1 Data Highlights
In its ongoing Phase 1 program, BGE-102 achieved 24-hour IC90 coverage at 60 mg once daily, demonstrating ~93% IL-1β suppression, ~86% hs-CRP reduction and ~50% IL-6 reduction in obese participants with elevated inflammation. The compound was well tolerated, with mild‐to‐moderate adverse events, and nonclinical toxicology studies showed 40- to 90-fold safety margins at the 60 mg dose.
2. Cardiovascular Trial Plans
BioAge will publish the full Phase 1 dataset in the first half of the year and initiate a three-month, placebo-controlled cardiovascular study in the second half, enrolling 50 patients on BGE-102 and 50 on placebo. CRP will serve as the primary endpoint to inform dose selection and assess broader inflammatory biomarker effects, including IL-6, fibrinogen and Lp(a).
3. Retinal Disease Expansion
BioAge plans a mid-year proof-of-concept trial in diabetic macular edema using a three-arm design (VEGF±BGE-102 and sham+BGE-102) based on preclinical data showing oral BGE-102 improves retinal vascular permeability and microvascular integrity. This oral approach aims to reduce injection burden and address systemic risk factors alongside local retinal inflammation.