BioAge Labs (NASDAQ:BIOA) outlined its strategy and near-term clinical plans at Oppenheimer’s 36th Annual Life Science Conference, emphasizing its focus on using human aging biology to develop therapies for metabolic disease. Co-founder and CEO Kristen Fortney was joined by team members BJ Sullivan and Dov Goldstein to discuss the company’s discovery platform, lead clinical program BGE-102, and a planned expansion into retinal diseases.
Platform built on longitudinal human aging data
Fortney said BioAge’s target discovery approach is centered on its BioAge Discovery Platform, which she described as one of the world’s largest collections of longitudinal human aging molecular data tied to functional outcomes. She said the platform includes more than 150 million molecular data points collected over decades and linked to outcomes such as longevity and chronic diseases including cardiovascular and metabolic disorders. Fortney said the platform has been validated through partnerships with Novartis and Eli Lilly focused on discovering drug targets and therapeutics.
Lead program: BGE-102, an oral brain-penetrant NLRP3 inhibitor
BioAge highlighted results from an ongoing Phase 1 program, including safety, pharmacokinetics, pharmacodynamics, and biomarker changes. Fortney said BGE-102 has demonstrated an attractive tolerability profile so far, with adverse events described as mild to moderate, self-limited, and without dose dependency. She also cited nonclinical safety margins of 40- to 90-fold at a 60 mg dose from one-month toxicology studies, and said the no-observed-adverse-effect level (NOAEL) was the highest dose tested in that study.
On pharmacology, Fortney highlighted what she described as potential best-in-class potency, including an IC90 of 1.8 nM in a human ex vivo whole-blood stimulation assay. She said the company has shown 24-hour IC90 coverage at 60 mg once daily in humans, with suppression of IL-1β greater than 90%, and that at 120 mg once daily the company can “fully suppress” IL-1β.
BioAge also emphasized central nervous system penetration. Fortney said the compound has shown high CNS penetration in humans, citing a Kp,uu CSF value of 0.7, and noted that drug levels in cerebrospinal fluid can exceed the IC90.
hs-CRP reductions in obese participants with elevated inflammation
Fortney discussed initial data from the multiple-ascending-dose portion of the Phase 1 study in obese participants with elevated baseline CRP. She said BioAge redesigned portions of the Phase 1 program after observing how quickly CRP changed in a comparable population in a Ventyx readout, enabling BioAge to evaluate dose-ranging effects on CRP directly in Phase 1.
In a cohort described as obese (BMI above 32) with CRP above 3 and without incretin treatment for 90 days, Fortney said that after about two weeks of once-daily dosing, 93% of treated individuals (13 of 14) were restored to hs-CRP below 2, which she framed as the threshold associated with improved outcomes in the CANTOS trial. She added that 86% reached that level by week one. Fortney said the biomarker change corresponded to an approximately 86% reduction in hs-CRP from baseline, with median baseline CRP around 4.85 to 5.
She also reported additional biomarker changes consistent with the mechanism, including about a 50% reduction in IL-6 and a 30% reduction in fibrinogen at day 14.
BioAge highlighted an exploratory observation related to CNS inflammation: among 14 participants, two had elevated IL-6 in CSF at baseline (above 7), and Fortney said IL-6 in CSF fell by 84% in those individuals. She said the company believes the effect reflected local CNS IL-6 rather than peripheral IL-6, noting the same individuals had lower IL-6 levels in plasma. Fortney also said IL-1β suppression at trough was about 93% in this cohort.
Development plans: cardiovascular-focused study and expansion into retinal disease
Fortney said BioAge plans to release a full Phase 1 dataset in the first half of the year, including CRP readouts across multiple doses in obese cohorts with elevated baseline inflammation. She said the Phase 1 work is intended to support dose selection for a larger trial planned for the second half of the year: a three-month, placebo-controlled monotherapy study of BGE-102 in obese participants with elevated CRP. Fortney said the planned study would include roughly 50 patients on BGE-102 and 50 on placebo, with CRP as the primary endpoint, along with broader inflammatory and metabolic biomarker assessments, including measures such as Lp(a), fibrinogen, IL-6, and MRI-based liver imaging.
On ophthalmology, Sullivan framed the rationale for evaluating BGE-102 in retinal diseases as an opportunity to introduce a new anti-inflammatory mechanism and reduce the burden associated with frequent intravitreal injections. He emphasized the potential patient benefit of an oral therapy, including the ability to treat bilateral disease and address systemic risk factors alongside retinal inflammation.
Sullivan said BioAge is initially targeting diabetic macular edema (DME) and also views geographic atrophy (GA) as promising. He described NLRP3 as central to disease biology in both indications, with different triggers (hyperglycemia and oxidative stress in DME; debris accumulation in GA) converging on inflammasome activation. He noted that NLRP3 inhibition could affect multiple downstream factors, including IL-6 and VEGF, and could address pyroptosis in endothelial cells.
BioAge presented preclinical data, including a streptozotocin-induced hyperglycemia mouse model showing dose-dependent correction of retinal vascular permeability with oral BGE-102 monotherapy and improved markers of microvascular integrity. Sullivan also cited a diet-induced obese mouse model in which BGE-102 monotherapy improved HOMA-IR (insulin resistance) in line with semaglutide.
BioAge said it plans to initiate a DME proof-of-concept trial in the middle of this year, with results expected in the middle of next year. Sullivan described a three-arm design that includes VEGF plus placebo, VEGF plus BGE-102, and a sham plus BGE-102 arm to evaluate potential monotherapy activity. He said the primary objective is to demonstrate a pharmacodynamic effect in the eye using aqueous taps and inflammatory biomarkers such as IL-6, with exploratory assessments including best-corrected visual acuity (BCVA) and central subfield thickness (CST).
Additional pipeline work and investor Q&A highlights
Beyond BGE-102, Fortney briefly discussed BioAge’s APJ agonism programs, which she described as potential “exercise mimetics” for obesity. She said the company is advancing both oral and injectable APJ candidates in preclinical development and remains on track to file INDs later this year.
In Q&A, Fortney said the full Phase 1 readout is primarily aimed at dose selection and assessing the durability of CRP reduction, which she expects to persist based on experience with similar mechanisms. She added that a three-month trial is important to evaluate longer-term safety and biomarker changes that may take longer to emerge than CRP, citing interest in liver-related signals and other cardiovascular-relevant biomarkers, including IL-18.
Asked about read-across from upcoming IL-6 cardiovascular outcomes data, Fortney said the field could gain additional evidence about how CRP reductions translate into major adverse cardiovascular event (MACE) benefits. She pointed to CANTOS as de-risking the downstream IL-1β mechanism and said additional readouts would be meaningful for BioAge and the broader field.
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.
-logo-1200x675.png&h=45&w=95&zc=2){kind=logo}
