Mirum's brelovitug hits main goal in late-stage hepatitis delta trial

Mirum Pharmaceuticals reported on Monday that its experimental hepatitis drug brelovitug met the main goal of a late-stage clinical study, reducing virus levels in patients with chronic hepatitis delta virus infection.

Brelovitug is a monoclonal antibody designed to bind to the hepatitis B surface antigen, a protein found on the surface of the virus. The therapy is being developed for chronic hepatitis delta, a liver infection that occurs only in people who are already infected with hepatitis B.

The condition can produce severe symptoms and may lead to liver damage or death. Mirum estimates that roughly 230,000 people in the United States and Europe are affected.

According to the company, 56% of patients who received a 300-milligram dose of brelovitug and 45% of those given a 900-milligram dose achieved a reduction in hepatitis D virus levels along with normal liver enzyme levels at 24 weeks. No patients in the delayed-treatment group reached the same endpoint.

Mirum said the treatment was well tolerated across dose groups, with a safety profile consistent with previously reported data.

Full results from the study are expected to be presented at an upcoming medical congress. The company plans to submit a marketing application for the drug to the US Food and Drug Administration in the first half of 2027.