BioAge Labs (NASDAQ:BIOA) used a presentation at the 25th Annual Needham Virtual Healthcare Conference to outline near-term clinical catalysts for its lead NLRP3 inflammasome inhibitor and provide updates on additional pipeline programs and its cash position.
Chief Financial Officer Dov Goldstein and Chief Strategy Officer BJ Sullivan described the company as a clinical-stage biotech applying “human aging biology as a lens for therapeutic development in cardiometabolic disease.” Sullivan said BioAge is “a platform-based company” with “one of the world’s largest collections of human aging data,” which it uses across discovery and development, including collaborations with Eli Lilly and Novartis.
Lead program focuses on inflammation in cardiometabolic disease and eye disease
BioAge is advancing BGE-102 into two therapeutic areas. The first is cardiovascular risk reduction, which Sullivan described as the lead indication. The second, announced in January, is ophthalmology, where the company plans to run a proof-of-concept study in diabetic macular edema (DME). Sullivan said the ophthalmology strategy is supported by “very strong rationale for NLRP3” and by the molecule’s ability to penetrate tissue, including “across the blood-retinal barrier.”
Phase 1 design and what BioAge expects to share next
Discussing BioAge’s phase 1 program, Sullivan said the trial includes a healthy volunteer single-ascending dose and multiple-ascending dose component, with multiple-ascending dose testing at 60 mg and 120 mg once daily. The company also extended the study to include two “obese, inflamed” multiple-ascending dose cohorts enrolling obese individuals with hs-CRP above 3 mg/L at baseline.
BioAge has reported results from the 120 mg obese cohort, which involved 14 days of treatment, and said it plans to disclose additional details from the 60 mg obese cohort in the first half of the year, with 21 days of treatment. Sullivan said the 60 mg cohort will help begin dose-response exploration and identify “the lowest dose where we can see maximum anti-inflammatory effects.”
On biomarkers, Sullivan said BioAge is focused on both percent reductions and normalization thresholds. He called hs-CRP below 2 mg/L clinically meaningful, citing CANTOS trial findings that patients who achieved that threshold showed a 25% MACE benefit, while those who did not “essentially had nothing.” He also noted BioAge has seen “a substantial proportion” of participants in the 120 mg group reach hs-CRP below 1 mg/L.
Sullivan said target engagement in healthy volunteer multiple-ascending dose cohorts included “90%–98% suppression of IL-1 beta,” and that the company saw anti-inflammatory effects in hs-CRP, IL-6, and fibrinogen in the reported obese cohort. In the coming update, BioAge also expects to provide unblinded adverse event information and additional discussion of safety and tolerability.
Planned cardiovascular and ophthalmology proof-of-concept studies
Sullivan said BioAge plans to initiate a dose-ranging cardiovascular risk proof-of-concept trial in the middle of the year, studying three dose levels of BGE-102 over three months, with data expected by year-end. He said a key goal is demonstrating durability of biomarker reductions over a longer treatment period, which he called critical for chronic disease settings.
For DME, Sullivan outlined an 8-week proof-of-concept study expected to start mid-year, with three arms of about 30 patients per arm:
- Anti-VEGF plus placebo
- Anti-VEGF plus BGE-102
- BGE-102 monotherapy
He said the trial’s key biomarker is intraocular IL-6, with the goal of showing a clear pharmacodynamic effect in the eye. Exploratory assessments will include best-corrected visual acuity (BCVA) and central subfield thickness (CST), though he emphasized the study is not powered for those endpoints.
APJ agonist programs and cash runway
Beyond NLRP3, Sullivan said BioAge is advancing two APJ agonist obesity programs—one oral and one parenteral—positioned as an adjunct to incretin therapies. He said preclinical studies have shown that combining an APJ agonist with an incretin can “double weight loss” and “fully restore body composition to that of lean controls.” BioAge expects to file its first IND for APJ by the end of the year.
On finances, Goldstein said BioAge ended last year with $285 million in cash and raised about $125 million net in the first quarter. He said the company’s budget—covering BGE-102 milestones, APJ proof-of-concept work, and CMC efforts—forecasts “more than three years of cash from this point.”
Asked about recent stock performance, Sullivan attributed momentum primarily to BGE-102 data and strategy updates, including the January disclosure of results from the first obese multiple-ascending dose cohort at 120 mg, which he said showed “potential for best-in-class efficacy.” He also pointed to broader interest in inflammatory approaches to ASCVD, including heightened attention around IL-6 and NLRP3 programs and anticipated data from Novo’s ZEUS study later in the year.
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.
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