BioAge Labs Begins Phase 2 Trial for Cardiovascular Drug BGE-102 in Partnership with HitGen
In a significant advancement for cardiovascular treatment, BioAge Labs, Inc., in collaboration with its partner HitGen Inc., has recently initiated Phase 2 clinical trials for its innovative drug, BGE-102. This trial marks a critical step in the development of a new oral NLRP3 inhibitor designed to reduce cardiovascular risks associated with aging and metabolic diseases.
BGE-102 stems from HitGen’s proprietary DNA-encoded library (DEL) technology, which has been instrumental in identifying promising compounds. The drug is formulated for once-daily oral administration, making it a more convenient option for patients. Early Phase 1 results reported by BioAge indicate that BGE-102 effectively reduces hsCRP levels—a biomarker associated with inflammation and cardiovascular disease—highlighting its potential as a game-changer in cardiovascular therapeutics.
The QUELL-CV trial, the Phase 2 study currently underway, is a randomized, double-blind, placebo-controlled trial aimed at determining the optimal dosage of BGE-102 for high-risk cardiovascular patients. With first results anticipated later in 2026, the insights gained from this study could be pivotal for advancing BGE-102 into subsequent trials and potentially into clinical use.
"We are thrilled to see BGE-102 reach this pivotal Phase 2 milestone," stated Jin Li, Chairman and CEO of HitGen. "This achievement not only underscores our DEL platform's capability to produce innovative small molecules targeting complex medical conditions but also highlights the power of our collaboration with BioAge. We are excited to continue this partnership as we work to advance this promising candidate forward."
Kristen Fortney, the CEO and co-founder of BioAge Labs, also expressed enthusiasm regarding the Phase 2 progression. "The transition to Phase 2 is a crucial milestone, emphasizing our collaboration with HitGen. Their DEL platform has uncovered groundbreaking NLRP3 inhibitors like BGE-102, which uniquely binds to a newly identified NLRP3 binding site and has shown promising results in reducing hsCRP levels during our Phase 1 trials. We eagerly look forward to pursuing new opportunities against other targets in our portfolio with HitGen."
HitGen, which operates a specialized drug discovery engine, has established itself as a leader in providing innovative therapeutic and tool molecules across the pharmaceutical sector. By the end of 2025, the company had built relationships with over 600 clients globally, playing a pivotal role in advancing various innovative drug development projects. The collaboration with BioAge represents a significant step towards realizing breakthrough treatments for cardiovascular diseases affecting millions worldwide.
The BGE-102 trial is not only a testament to the advancement in cardiovascular therapies but also a celebration of collaborative innovation in biopharmaceuticals—promising a healthier future through scientific progress. As the study unfolds, the medical community and patients alike await the potential benefits this groundbreaking drug may offer in the fight against cardiovascular illnesses.