BioAge Labs Announces Additional Interim Data From Ongoing Phase 1 Clinical Trial Evaluating BGE-102, Brain-Penetrant Small Molecule NLRP3 Inhibitor For Treatment Of Patients With Cardiovascular Risk Factors
Benzinga Newsdesk 9 months ago
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First BGE-102 MAD cohort completed in obese individuals with elevated hsCRP receiving 120 mg QD; demonstrated rapid and profound reduction in inflammatory markersBGE-102 achieved 86% reduction in hsCRP at Day 14, with
First BGE-102 MAD cohort completed in obese individuals with elevated hsCRP receiving 120 mg QD; demonstrated rapid and profound reduction in inflammatory markers
BGE-102 achieved 86% reduction in hsCRP at Day 14, with 93% of participants reaching normalized levels (<2 mg/L)
BGE-102 demonstrated significant reductions in IL-6, a key driver of systemic inflammation and cardiovascular risk, and fibrinogen, an independent predictor of cardiovascular events
BGE-102 was well tolerated with a favorable safety profile
Patent issued covering additional composition of matter and novel NLRP3 binding site
Full Phase 1 data, including additional MAD cohorts in obese participants with elevated hsCRP, anticipated 1H 2026; Phase 2a study on track to initiate in 1H 2026
EMERYVILLE, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ:BIOA) ("BioAge"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced additional positive interim data from the ongoing Phase 1 clinical trial evaluating BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for the treatment of patients with cardiovascular risk factors.
In a multiple ascending dose (MAD) cohort of participants with obesity (BMI 32–42) and elevated baseline inflammation (hsCRP >3 mg/L), BGE-102 120 mg once daily achieved an 86% median reduction in high-sensitivity C-reactive protein (hsCRP) at Day 14. Notably, 93% of BGE-102-dosed participants (13 of 14) achieved hsCRP levels below 2 mg/L—the clinically recognized threshold for reduced cardiovascular risk.
These findings build on positive interim data announced in December 2025 from SAD and initial MAD cohorts, which demonstrated that BGE-102 was well tolerated, achieved dose-proportional pharmacokinetics supporting once-daily dosing, and produced 90-98% suppression of IL-1β at Day 14 trough. Those data also confirmed high brain penetration, with cerebrospinal fluid (CSF) concentrations exceeding the IC90 at doses of 60 mg and above.