120 mg and newly announced 60 mg once-daily doses each achieved ≥85% median hsCRP reductions in participants with obesity and elevated baseline inflammation
BGE-102 was well tolerated across all dose levels
Phase 2 proof-of-concept trial in cardiovascular risk planned to initiate mid-2026, with results anticipated by end of year
Phase 1b/2a proof-of-concept trial in diabetic macular edema (DME) planned to initiate mid-2026, with results anticipated mid-2027
BioAge to host conference call and webcast today at 8:00 AM ET to discuss BGE-102 results
EMERYVILLE, Calif., April 21, 2026 (GLOBE NEWSWIRE) — 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.
Conference Call and Webcast
BioAge management will host a conference call and webcast to review the Phase 1 results at 8:00 AM ET, April 21, 2026. Registration information is available here.
About BGE-102 and NLRP3
BGE-102 is a structurally novel, potent, orally available, brain-penetrant small molecule NLRP3 inhibitor discovered by BioAge. NLRP3 is a central driver of age-related chronic inflammation that has been implicated in cardiovascular disease, metabolic disorders including obesity, and neurodegenerative conditions. BioAge’s discovery platform identified NLRP3 as a therapeutic target based on analysis of human aging cohorts, which revealed that reduced NLRP3 activity is associated with greater longevity.
About BioAge Labs, Inc.
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company’s lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated in H2 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid 2027. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Forward-looking statements
This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102, the potential for BGE-102 as a treatment for cardiovascular diseases and retinal diseases including diabetic macular edema, the expected timing of clinical trials, the timing and results of our clinical activities, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2026, and BioAge’s other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts
PR: Chris Patil, [email protected]
IR: Dov Goldstein, [email protected]
Partnering: Peng Leong, [email protected]
Web: https://bioagelabs.com
