CHENGDU, China, July 14, 2026
HitGen Inc. has announced that its partner BioAge Labs has dosed the first participant in the QUELL-CV Phase II proof-of-concept clinical trial evaluating BGE-102, a novel oral NLRP3 inhibitor being developed to reduce cardiovascular risk. The milestone represents a significant advancement for a drug candidate originally discovered through HitGen’s industry-leading DNA-Encoded Library (DEL) technology platform, demonstrating the platform’s ability to generate innovative small-molecule therapeutics for challenging biological targets. BGE-102 is a potent, structurally novel, brain-penetrant, once-daily oral therapy designed to inhibit the NLRP3 inflammasome, a key driver of chronic inflammation linked to cardiovascular disease and other inflammatory disorders. Following encouraging Phase I clinical results, which demonstrated a favorable safety profile and substantial reductions in high-sensitivity C-reactive protein (hsCRP), the investigational therapy has now entered Phase II development to evaluate its potential in reducing cardiovascular risk. The QUELL-CV trial is expected to provide critical data supporting dose selection for future Phase III clinical studies, with topline results anticipated during the second half of 2026.
Phase II Trial Evaluates Novel Oral NLRP3 Inhibitor
The QUELL-CV study is a randomized, double-blind, placebo-controlled, dose-ranging Phase II clinical trial designed to evaluate the safety, efficacy, and optimal dosing strategy for BGE-102 in individuals at elevated cardiovascular risk. The study aims to determine whether inhibiting the NLRP3 inflammasome, an important regulator of inflammatory signaling associated with atherosclerosis and cardiovascular disease progression, can reduce inflammatory biomarkers and improve long-term cardiovascular outcomes. Earlier Phase I clinical data positioned BGE-102 as a potentially best-in-class NLRP3 inhibitor, demonstrating significant reductions in hsCRP while maintaining a well-tolerated safety profile through convenient once-daily oral dosing. The findings from QUELL-CV will play an important role in defining the drug’s future development pathway and supporting advancement into late-stage registrational studies.
HitGen’s DEL Platform Drives Innovative Drug Discovery
The successful progression of BGE-102 into Phase II development highlights the growing impact of HitGen’s DNA-Encoded Library (DEL) technology, one of the world’s largest small-molecule discovery platforms containing more than 1.2 trillion compounds. The collaboration between HitGen and BioAge Labs began with the identification of structurally novel NLRP3 inhibitor hit molecules, which were subsequently optimized into BGE-102 through medicinal chemistry and translational research. The partnership has already generated joint scientific publications and patent filings, while both companies continue collaborating on additional drug discovery programs targeting novel disease pathways. By integrating DEL technology, artificial intelligence, automation, and complementary medicinal chemistry platforms, HitGen has established a globally recognized drug discovery engine supporting more than 600 pharmaceutical and biotechnology partners across thousands of research programs.
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Strategic Collaboration Expands Precision Cardiometabolic Innovation
The advancement of BGE-102 reflects the increasing importance of collaborative innovation in developing next-generation therapies for cardiometabolic diseases and age-related disorders. Beyond cardiovascular disease, BioAge Labs is also investigating BGE-102 for retinal diseases, including diabetic macular edema, highlighting the broader therapeutic potential of targeting chronic inflammatory pathways. The continued success of the HitGen-BioAge partnership reinforces confidence in DEL-enabled drug discovery while demonstrating how strategic collaborations can accelerate the translation of early scientific discoveries into clinical-stage therapeutics. As Phase II QUELL-CV progresses toward completion, both companies are positioned to generate important clinical evidence supporting the future development of precision anti-inflammatory medicines capable of addressing major unmet needs in cardiovascular healthcare.
Source: HitGen press release
