공시 • Apr 23
Bioage Labs, Inc. Reports Positive Phase 1 Data for BGE-102, A Novel Oral Nlrp3 Inhibitor Demonstrating Potential Best-In-Class Reductions in hsCRP
BioAge Labs, Inc. reported results from the Phase 1 clinical trial of BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor. The full dataset, which includes a newly announced 60 mg once-daily cohort dosed for 21 days in participants with obesity and elevated inflammation, demonstrates that BGE-102 achieved potential best-in-class reductions in high-sensitivity C-reactive protein (hsCRP) and consistent reductions across multiple inflammatory biomarkers, with a favorable tolerability profile. Notably, the 60 mg dose achieved hsCRP and other biomarker reductions comparable to the previously reported 120 mg dose. Based on the full Phase 1 dataset, BioAge intends to initiate a dose-ranging Phase 2 cardiovascular risk proof-of-concept trial in the first half of 2026, with data anticipated in the second half of 2026. The Phase 1 trial was a randomized, double-blind, placebo-controlled trial in healthy volunteers and participants with obesity, with primary endpoints of pharmacokinetics and safety and exploratory pharmacodynamic endpoints including inflammatory biomarkers. The multiple ascending dose (MAD) portion of the study enrolled healthy volunteers and participants with obesity (BMI 32–42) with elevated systemic inflammation (hsCRP >3 mg/L). The two obese MAD cohorts are reported here: 120 mg once daily for 14 days and 60 mg once daily for 21 days. Prior results from single ascending dose (SAD) and MAD cohorts in healthy volunteers, including pharmacokinetics, brain penetration, and IL-1ß suppression data, and additional results from the 120 mg obese MAD cohort, were reported previously. BGE-102 demonstrated rapid, profound, and sustained reductions in hsCRP at both dose levels, with comparable percent median reductions from baseline: 60 mg QD (21-day dosing): 85% reduction at Day 7, 80% at Day 14, 86% at Day 21; 87% of participants on active treatment (13/15) achieved normalized hsCRP (<2 mg/L) at Day 21, with 60% (9/15) reaching =1 mg/L. 120 mg QD (14-day dosing): 83% reduction at Day 7, 86% at Day 14; 93% of participants on active treatment (13/14) achieved normalized hsCRP (<2 mg/L) at Day 14, with 71% (10/14) reaching =1 mg/L. Reductions in IL-6, a clinically validated inflammatory mediator of cardiovascular risk, were consistent with hsCRP findings at both dose levels, confirming potent upstream NLRP3 inflammasome inhibition: 60 mg QD: 78% reduction at Day 7, 70% at Day 14, 55% at Day 21; 120 mg QD: 69% reduction at Day 7, 58% at Day 14. Reductions in fibrinogen, an established cardiovascular risk marker, were observed at both dose levels: 60 mg QD: 20% reduction at Day 7, 19% at Day 14, 23% at Day 21; 120 mg QD: 24% reduction at Day 7, 30% at Day 14. Based on the complete Phase 1 dataset, BioAge plans to initiate a Phase 2 dose-ranging proof-of-concept trial evaluating BGE-102 in participants at elevated cardiovascular risk in the first half of 2026, with data anticipated in the second half of 2026. Three oral once-daily dose levels will be assessed, with hsCRP as the primary endpoint. The trial is designed to support optimal dose selection for Phase 3. Additional trial design details are available in the Company's corporate presentation. BioAge also plans to initiate a Phase 1b/2a proof-of-concept study evaluating BGE-102 in patients with DME in mid-2026, with results anticipated in mid-2027. The trial is designed to demonstrate pharmacodynamic target engagement for BGE-102 in the eye, supporting future development in inflammation-driven retinal diseases. Additional details on the ophthalmology program can be found in the corporate presentation.