BioAge Labs (NASDAQ:BIOA) executives outlined the company’s development plans for its lead NLRP3 inhibitor, BGE-102, and a pipeline of APJ agonists, emphasizing upcoming clinical readouts in cardiovascular risk and ophthalmology.
BJ Sullivan, chief strategy officer at BioAge Labs, described the company as a clinical-stage biotechnology firm using human aging biology to identify targets and develop therapies for cardiometabolic disease. He said BGE-102 is the company’s lead program and a potential best-in-class oral NLRP3 inhibitor.
BGE-102 Positioned for Cardiovascular Risk Study
BioAge is developing BGE-102 first in cardiovascular disease. Sullivan said the company is conducting a cardiovascular risk proof-of-concept, dose-ranging Phase 2 study that is expected to read out by the end of this year. The primary outcome is CRP reduction, with additional inflammatory biomarkers and safety and tolerability also being evaluated.
He said the study is also designed to support dose selection for a potential Phase 3 program. BioAge is evaluating a top dose of 90 milligrams once daily in Phase 2, compared with 120 milligrams used in Phase 1. Sullivan said the company expects the lower dose to deliver about 98% target suppression at steady state, based on the drug’s pharmacokinetic profile.
Sullivan said BGE-102’s mechanism targets NLRP3, an inflammasome involved in sterile inflammation. In ASCVD, he said triggers such as cholesterol crystals, oxidized LDL, metabolic stress and hyperglycemia can activate NLRP3, leading to production of inflammatory cytokines including IL-1 beta and IL-18.
BioAge believes BGE-102 differs from earlier NLRP3 programs because it binds to a novel site. Sullivan said the company used a DNA-encoded library approach to identify a binding pocket distinct from the ATPase pocket targeted by MCC950-derived compounds. He said BioAge’s binding site is accessible whether NLRP3 is active or inactive, which may contribute to the onset and magnitude of biomarker effects observed in early testing.
Ophthalmology Becomes Second Anchor Area
BioAge is also moving BGE-102 into ophthalmology, including diabetic macular edema, or DME, and geographic atrophy. Sullivan said the company expects to initiate a DME proof-of-concept study in the middle of this year, with results expected in the middle of next year.
The planned DME study will include three arms: BGE-102 monotherapy, anti-VEGF monotherapy and BGE-102 in combination with anti-VEGF therapy. Sullivan said the primary endpoint will be percentage change in intraocular IL-6, measured through aqueous taps. He said the study is powered for about a 40% change in IL-6, while also tracking functional and anatomical measures including best-corrected visual acuity and central subfield thickness.
Sullivan said NLRP3 is relevant in DME because hyperglycemia can activate inflammatory signaling in the eye. In geographic atrophy, he said the rationale is tied to accumulation of cellular debris such as drusen, which can act as a pro-inflammatory trigger.
He also cited Roche’s vamikibart program as informative, saying its data support the concept that selective anti-inflammatory approaches may provide benefit in DME. Sullivan said an oral therapy could be useful for DME patients who are currently monitored but not yet treated with intravitreal therapy, as well as later-stage patients who remain insufficiently controlled on anti-VEGF treatment.
APJ Agonists Target Obesity and Body Composition
Beyond BGE-102, BioAge is developing oral and subcutaneous APJ agonists. Sullivan said APJ is the receptor for apelin, an exercise-induced “exerkine” secreted by muscle. He said BioAge’s platform identified apelin as associated with longevity and preservation of physical function.
In preclinical work, Sullivan said adding an APJ agonist to an incretin doubled weight loss and restored body composition to levels seen in lean control animals. He said BioAge is pursuing both oral and injectable approaches to complement evolving obesity treatments, with potential roles in increasing weight loss for oral regimens and improving body composition for injectable incretin-based therapies.
The company also has a collaboration with JiKang Therapeutics focused on an agonist nanobody, Sullivan said.
Partnerships and Cash Position
Sullivan discussed BioAge’s collaborations with Novartis and Eli Lilly. He said the Novartis partnership is focused on target discovery at the intersection of healthy aging and exercise, using BioAge’s human aging datasets and Novartis’ exercise intervention datasets. The Lilly collaboration is focused on molecule discovery against targets identified through BioAge’s platform.
Dov Goldstein, chief financial officer at BioAge Labs, said the company had $385 million in cash at the end of the first quarter. He said the company’s cash runway extends into 2026 and includes the programs discussed, as well as work on a backup NLRP3 compound.
Goldstein said a follow-on NLRP3 molecule could provide flexibility if BioAge partners the ASCVD opportunity while retaining ophthalmology for itself. Regarding potential partnerships, he said BioAge believes the best position from which to form a partnership is to be prepared to advance the asset independently.
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.
