BioAge Labs, Inc. (Nasdaq: BIOA) (“BioAge” or the “Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today 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.
“These Phase 1 results position BGE-102 as a potential best-in-class NLRP3 inhibitor, delivering profound hsCRP reductions with a well-tolerated once-daily oral dose,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “These data give us strong conviction to accelerate the program across multiple indications. BGE-102’s potency and tissue penetration make it a potential pipeline in a pill — a single oral therapy to address NLRP3-driven inflammation in cardiovascular, ocular, and CNS diseases. We are rapidly advancing BGE-102 with a Phase 2 dose-ranging trial in cardiovascular risk, a Ph1b/2a proof-of-concept trial in diabetic macular edema, and full investment in CMC, regulatory, and clinical activities to enable Phase 3 initiation in 2027.”
“hsCRP is among the most predictive biomarkers of cardiovascular risk, and targeting inflammation is a clinically validated strategy: prior interventional data for anti-inflammatory therapies demonstrated that reducing hsCRP below 2 mg/L was associated with a 25% reduction in major adverse cardiovascular events,” said Paul Rubin, M.D., Chief Medical Officer of BioAge. “We believe a convenient, well-tolerated oral medicine has broad potential in ASCVD secondary prevention — and potentially in primary prevention as well. These data, demonstrating potent effects across multiple clinically established drivers of cardiovascular risk, suggest that NLRP3 inhibition could have transformational potential, much as statins did for LDL cholesterol decades ago.”
Phase 1 Trial Design
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-1β suppression data, and additional results from the 120 mg obese MAD cohort, were reported previously.
Biomarker Efficacy in Participants with Obesity and Elevated hsCRP
hsCRP
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
IL-6
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
Fibrinogen
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
Additional data from the BGE-102 Phase 1 trial are available in the Company’s corporate presentation, which can be found on the Investors section of the Company’s website.
Safety and Tolerability
BGE-102 was well tolerated across all dose levels evaluated in the Phase 1 study. All treatment-emergent adverse events (TEAEs) were mild to moderate in severity and self-limited, with no dose dependency. There were no serious adverse events, TEAEs leading to discontinuation, or clinically meaningful changes in vital signs, ECGs, or laboratory values.
BGE-102 Planned Development Program
Cardiovascular risk proof-of-concept trial
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.
Proof-of-concept trial in diabetic macular edema (DME)
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.
More information can be found on the official press release.
View the article at lifespan.io
