BioAge Labs Eyes Key BGE-102 Readouts in Heart Risk and Diabetic Eye Disease

BioAge Labs (NASDAQ:BIOA) executives used a fireside chat at the Jefferies 2026 Global Healthcare Conference to outline the company’s plans for BGE-102, its lead NLRP3 inhibitor, with near-term readouts expected in cardiovascular risk and diabetic macular edema.

The company’s chief business officer, referred to in the transcript as BJ, said BioAge is a clinical-stage biotech founded on the idea that human aging biology can be used to identify drug targets for cardiometabolic disease. He described BGE-102 as a potential best-in-class NLRP3 inhibitor being developed for cardiovascular disease and ophthalmology.

BioAge reported Phase 1 results for BGE-102 a few months ago and is now running a Phase 2 cardiovascular risk dose-ranging study, with results expected by the end of the year. The company also plans to initiate a proof-of-concept trial in diabetic macular edema, or DME, in the middle of the year, with data expected in the middle of next year.

BioAge Points to Biomarker Reductions in Phase 1

BJ said interest in NLRP3 inhibition has increased following clinical data from Ventyx and broader attention on inflammatory pathways in cardiovascular disease. He noted that Ventyx reported three-month data showing efficacy “approaching” injectable biologic modalities and was later acquired by Lilly.

BioAge’s Phase 1 trial included two cohorts of obese participants with elevated CRP at baseline, which BJ said were similar to the patients studied by Ventyx. In those cohorts, BioAge tested 60 mg for three weeks and 120 mg once daily for two weeks.

According to BJ, BioAge observed an 86% reduction in high-sensitivity CRP, or hsCRP, in both cohorts. He also said CRP normalized to below 2 mg per liter in 87% of patients in the 60 mg cohort and 93% in the 120 mg cohort.

He said those results were important in light of the CANTOS trial of canakinumab in atherosclerotic cardiovascular disease, where the overall MACE reduction was 15%, but patients who achieved hsCRP below 2 mg per liter had a 25% benefit, while nonresponders had essentially no benefit.

Phase 2 Trial Aims to Support Dose Selection

BioAge is evaluating 30 mg, 60 mg and 90 mg once-daily doses in its Phase 2 trial. BJ said 90 mg is expected to deliver about 98% inhibition of the target, while the company expects 30 mg may produce a suboptimal biomarker response based on modeling.

The Phase 2 trial will treat patients for three months and is intended to show stable reductions in inflammatory biomarkers, while also expanding the safety and tolerability dataset. BJ said BioAge will add assessments that require longer treatment, including MRI imaging of liver fat content and liver inflammation.

He said the company wants to finish the year with confidence in dose selection for a potential Phase 3 trial. BioAge has also begun chemistry, manufacturing and controls work to support a future Phase 3 start.

Safety, Differentiation and Cardiovascular Strategy

Asked about safety, BJ said inflammasome inhibition differs from cytokine neutralization. He said NLRP3 is a key sensor of sterile inflammation, while other inflammasomes remain available in pathogen responses. He also pointed to Ventyx’s three-month safety database, BioAge’s Phase 1 tolerability profile and the company’s preclinical toxicology work, citing a 50- to 100-fold safety margin based on three-month GLP toxicology to date.

BJ said one differentiating feature of BGE-102 is its brain penetration, citing a Kp,uu,CSF of 0.7 in the Phase 1 trial. He said central nervous system exposure may allow BioAge to address a broader range of NLRP3-driven diseases and could be relevant even in conditions that appear peripheral, such as ASCVD.

The executives also discussed the Novo Nordisk ZEUS trial of the IL-6 program ziltivekimab, expected in the third quarter. BJ said any significant MACE reduction would be “really exciting” and would help validate the idea that targeting the inflammatory axis can produce cardiovascular benefit.

For BioAge’s own ASCVD strategy, BJ said the base case would be an outcomes trial measuring MACE. Dov Goldstein, BioAge’s chief financial officer, said the company must be prepared to proceed independently and quickly, while remaining open to the possibility that a larger partner could run a MACE study. Goldstein said BioAge had about $385 million at the end of the first quarter, which he said provides substantial funding toward a potential MACE study.

DME Trial Will Test Eye Biomarkers and Clinical Signals

BioAge is also advancing BGE-102 in ophthalmology, starting with DME. BJ said the molecule has shown therapeutic retinal exposures across preclinical species and that an oral anti-inflammatory approach could be relevant across multiple eye diseases.

The planned DME study will include three arms: BGE-102 monotherapy, VEGF monotherapy and VEGF plus BGE-102. The primary endpoint will be intraocular IL-6, measured through aqueous taps. BioAge will also evaluate functional and anatomical measures, including best-corrected visual acuity and OCT imaging.

BJ said the goal is to show a clear pharmacodynamic effect in the eye and potentially see trends in clinical and anatomical endpoints that align with biomarker reductions. He also said geographic atrophy is another high-priority ophthalmology indication for the company.

APJ Programs and Obesity Question

Beyond BGE-102, BioAge is developing oral and subcutaneous APJ agonist programs. BJ said the target is associated with longevity and preservation of physical function and could potentially complement incretin therapies in obesity by improving the quantity and quality of weight loss. The company is guiding to filing its first IND for the program by the end of the year.

Asked whether BGE-102 could show a weight-loss signal in the ongoing 12-week study, BJ said that would be “surprise upside” and that BioAge views the likelihood as low, particularly given Ventyx did not show such an effect. He said the study will include patients with BMIs between 32 and 42 and will provide data by year-end.

About BioAge Labs (NASDAQ:BIOA)

BioAge Labs (NASDAQ: BIOA) is a clinical-stage biotechnology company focused on discovering and developing therapies that address age-associated diseases. The company leverages its proprietary analytics platform to mine large-scale human biological data for insights into the molecular mechanisms of aging. By targeting fundamental aging pathways, BioAge aims to create interventions that extend healthspan and treat conditions that disproportionately affect older populations.

At the core of BioAge’s operations is its integrated drug discovery platform, which combines human omics datasets, machine learning algorithms and experimental validation to identify novel drug targets.