Clinical trial authorizations obtained from New Zealand and the United Kingdom build on prior approval in Hong Kong, further expanding the company’s global clinical footprint

nChroma Bio (“nChroma”), a clinical-stage, genetic medicines company advancing in vivo delivery of innovative cargoes, today announced that the first patient has been dosed in the company’s Phase 1/2 clinical trial evaluating CRMA-1001, its investigational epigenetic silencer designed to achieve functional cure for chronic hepatitis B virus (HBV) infection. The company has also received additional CTA approvals in New Zealand and the UK, enabling initiation of the study in those countries.

“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 an optimized next generation epigenetic therapy designed to durably silence viral antigen expression and HBV replication by methylating both covalently closed circular (cccDNA) and integrated HBV DNA (intDNA) without genome cutting. Preclinical data demonstrated robust and durable suppression of hepatitis B surface antigen (HBsAg) and HBV DNA across models, supporting the translational potential of this approach.

The open-label Phase 1/2 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CRMA-1001 in adults with chronic hepatitis B across single- and multiple-ascending dose cohorts. Additional clinical site openings and patient enrollment are underway. See ClinicalTrials.gov for further information: NCT07200193

“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.”

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 people with 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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"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.