BOSTON, Mass. — nChroma Bio said it has received authorization to initiate a Phase 1/2 clinical trial of its lead candidate CRMA-1001 for the treatment of chronic hepatitis B virus (HBV) infection, marking the company’s transition to a clinical-stage biotechnology firm.
The genetic medicines company said it received a Certificate for Clinical Trial in Hong Kong, clearing the way for the first-in-human study of CRMA-1001, an epigenetic silencer designed to durably suppress HBV. First patient dosing in the Phase 1/2 trial is planned for early 2026.
Chronic hepatitis B affects more than 250 million people worldwide and remains a major cause of liver cirrhosis and liver cancer. Current therapies rarely achieve a functional cure, leaving a significant unmet need for finite-course, durable treatments.
CRMA-1001 is an optimized next-generation epigenetic silencer engineered to suppress HBV antigen expression by methylating both covalently closed circular DNA (cccDNA) and integrated HBV DNA without cutting or nicking the genome. The company said this approach has the potential to deliver deeper and more sustained viral control compared to existing and investigational therapies.
“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.”
The trial will be conducted in Hong Kong, with Professor Man-Fung Yuen serving as a principal investigator. Professor Yuen is Chair Professor at The University of Hong Kong, Li Shu Fan Medical Foundation Professor of Medicine, and Chief of the Division of Gastroenterology and Hepatology at Queen Mary Hospital. He is widely recognized for his work in hepatitis B research, with more than 630 publications in leading medical journals.
“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.”
Preclinical data presented at The Liver Meeting® 2025 of the American Association for the Study of Liver Diseases showed that CRMA-1001 achieved durable hepatitis B surface antigen loss and HBV DNA silencing across multiple models. In mouse studies, up to 90 percent of treated animals achieved undetectable combined DNA and HBsAg levels. Additional studies in non-human primates using a surrogate liver target supported the candidate’s efficacy, durability, and safety.
nChroma said the results underscore the potential of its next-generation epigenetic silencing approach to achieve a durable functional cure for people living with chronic hepatitis B.
