BioAge reported positive phase 1 results for BGE-102, a novel oral, brain-penetrant NLRP3 inhibitor, from a randomized, double-blind, placebo-controlled multiple ascending dose study that included healthy volunteers and participants with obesity and elevated inflammation.
The full dataset shows both 60 mg once daily (21 days) and 120 mg once daily (14 days) produced rapid and large median reductions in high-sensitivity C-reactive protein; the 60 mg cohort recorded median reductions of 85% at day 7, 80% at day 14, and 86% at day 21, with 87% (13/15) of treated participants normalizing hsCRP to below 2 mg/L at day 21.
The 120 mg cohort showed median reductions of 83% at day 7 and 86% at day 14, with 93% (13/14) normalizing hsCRP at day 14. Reductions in IL-6 and fibrinogen were also reported.
BGE-102 was reported to be well tolerated across dose levels, with treatment-emergent adverse events described as mild to moderate, no serious adverse events, no discontinuations for adverse events, and no clinically meaningful changes in vital signs, ECGs, or laboratory values.
The company claims these findings position BGE-102 as a potential best-in-class NLRP3 inhibitor. According to the company, a Phase 2 dose-ranging cardiovascular risk proof-of-concept trial is planned to initiate in mid-2026, with data anticipated in the second half of 2026, and a Phase 1b/2a diabetic macular edema trial is planned for mid-2026, with results expected in mid-2027.
