BOSTON — nChroma Bio said it has dosed the first patient in its Phase 1/2 clinical trial evaluating CRMA-1001, an investigational epigenetic silencer designed to achieve a functional cure for chronic hepatitis B virus infection.
The company said the milestone follows the receipt of additional clinical trial authorizations in New Zealand and the United Kingdom, building on prior authorization in Hong Kong and further expanding nChroma’s global clinical footprint.
“We are proud to reach this important clinical milestone,” said Jeff Walsh, Chief Executive Officer of nChroma Bio. “Dosing the first participant in our Phase 1/2 study is a key step toward evaluating CRMA-1001’s potential to provide clinically meaningful and durable responses for people living with chronic HBV, a disease that affects hundreds of millions worldwide and for which existing treatments are rarely curative.”
CRMA-1001 is a next-generation epigenetic therapy designed to durably silence viral antigen expression and hepatitis B virus replication by methylating both covalently closed circular DNA and integrated HBV DNA without cutting the genome. Preclinical studies demonstrated robust and durable suppression of hepatitis B surface antigen and viral DNA across multiple models, supporting the translational potential of the approach.
The open-label Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CRMA-1001 in adults with chronic hepatitis B through single- and multiple-ascending dose cohorts. Additional clinical site activations and patient enrollment are ongoing.
“Dosing the first participant underscores the progress we’ve made in advancing our highly optimized and potentially best-in-class epigenetic silencer,” said Jenny Marlowe, Ph.D., Chief Development Officer of nChroma Bio. “We look forward to generating early clinical insights that will inform the future development of CRMA-1001 and potentially reshape the therapeutic landscape for chronic hepatitis B.”
