First CTA authorization marks nChroma’s transition to a clinical-stage company; first patient dosing in Phase 1/2 trial planned for early 2026
Preclinical studies demonstrated CRMA-1001 delivers durable HBV antigen loss and HBV DNA silencing across multiple models
BOSTON–(BUSINESS WIRE)–#ClinicalTrials–nChroma Bio (“nChroma”), a genetic medicines company advancing in vivo delivery of innovative cargoes to overcome the limitations of existing therapies, today announced that it has received a Certificate for Clinical Trial in Hong Kong to initiate a Phase 1/2 clinical trial of its lead candidate CRMA-1001 for the treatment of chronic hepatitis B virus (HBV) infection.
With over 250 million people worldwide living with HBV, there is a significant unmet need to develop life-long, finite-course curative treatments for this chronic disease. CRMA-1001 is an optimized next-generation epigenetic silencer, designed to durably silence HBV antigen expression by methylating both covalently closed circular DNA (cccDNA) and integrated HBV DNA (intDNA) without cutting or nicking the genome. This innovative strategy has the potential to provide a functional cure for the millions living with this chronic disease.
“This regulatory clearance marks a defining milestone for nChroma and for patients affected by chronic HBV,” said Jeff Walsh, Chief Executive Officer of nChroma Bio. “We see a real opportunity to change the trajectory of chronic hepatitis B by delivering deeper, more sustained responses driven by potentially best-in-class potency, going beyond the limits of existing and investigational treatments.”
Professor Man-Fung Yuen, a top internationally recognized researcher in the field of hepatitis B and Chair Professor of The University of Hong Kong, Li Shu Fan Medical Foundation Professor of Medicine, and the Chief of the Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong, will serve as a principal investigator in the trial. Professor Yuen has published more than 630 papers in world-renowned journals including New England Journal of Medicine, Lancet, and Nature Medicine, and he has delivered more than 360 lectures around the world.
“Hepatitis B remains a major global public health challenge that can lead to life-threatening conditions such as cirrhosis and liver cancer,” said Professor Yuen. “I am honored to serve as a Principal Investigator for the Phase 1/2 clinical trial of CRMA-1001 here in Hong Kong. As a novel epigenetic silencer, I am enthusiastic about the promising potential of CRMA-1001 to achieve functional cure for persons living with HBV and I look forward to contributing to the development effort that could change the future for millions of people worldwide.”
At The Liver Meeting® 2025 of the American Association for the Study of Liver Diseases (AASLD), data presented demonstrates CRMA-1001 achieves durable hepatitis B surface antigen (HBsAg) loss and HBV DNA silencing across multiple preclinical models, with up to 90% of treated mice achieving undetectable combined DNA & HBsAg levels. Studies in non-human primates using surrogate liver target PCSK9 further support the efficacy, durability and safety of CRMA-1001. These findings underscore the potential of CRMA-1001’s next generation epigenetic silencing approach to achieve durable functional cure for individuals living with chronic HBV.
About nChroma Bio
nChroma Bio is a genetic medicines company committed to addressing the limitations of existing therapies through a disease-first approach. By combining programmable in vivo delivery and gene-regulating technologies, nChroma is designing optimal solutions to deliver precise, potent and durable treatments for patients with high unmet needs. nChroma’s lead candidate, CRMA-1001, is a clinical-stage, liver-directed epigenetic silencer in development as a potential functional cure for chronic hepatitis B. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, nChroma is redefining targeted in vivo genetic medicine with the initial goal of treating diseases affecting the liver, blood, and central nervous system. For more information, visit nChromaBio.com and follow us on LinkedIn and X.
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