Core Insights - BioAge Labs, Inc. announced positive interim data from the Phase 1 clinical trial of BGE-102, a novel NLRP3 inhibitor aimed at treating cardiovascular risk factors, showing significant reductions in inflammatory markers [1][4][9] Group 1: Clinical Trial Results - In a multiple ascending dose (MAD) cohort, BGE-102 at 120 mg once daily achieved an 86% median reduction in high-sensitivity C-reactive protein (hsCRP) at Day 14, with 93% of participants reaching hsCRP levels below 2 mg/L [2][7] - BGE-102 also demonstrated a 44% median reduction in serum IL-6 at Day 14, indicating its effectiveness in reducing systemic inflammation [6][12] - The drug achieved an 83% median reduction in hsCRP from a baseline of 4.85 mg/L at Day 7 and maintained an 86% reduction at Day 14 [7][9] Group 2: Safety and Tolerability - BGE-102 was well tolerated, with adverse events being infrequent, mild to moderate in severity, and self-limited, showing no dose-dependent pattern [12][14] - No dose-limiting toxicities were observed during the trial [12] Group 3: Future Development Plans - Full Phase 1 data, including additional MAD cohorts, is anticipated in the first half of 2026, with a Phase 2a study set to initiate in the same timeframe [1][13] - The Phase 2a study will evaluate BGE-102's effects on inflammatory biomarkers over a longer duration in patients with elevated cardiovascular risk [9][13] Group 4: Mechanism and Innovation - BGE-102 represents a structurally novel class of NLRP3 inhibitors with a unique mechanism and binding site, targeting age-related inflammation implicated in various diseases [14][15] - The drug's high brain penetration was confirmed, with cerebrospinal fluid concentrations exceeding the IC90 at doses of 60 mg and above [3][12]
BioAge Announces Additional Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor, Demonstrating Potential for Best-in-Class hsCRP Reduction in Participants with Elevated Cardiovascular Risk