Mirum Pharmaceuticals says its experimental hepatitis drug, brelovitug, has achieved the main goal of a late-stage clinical trial.
The company reported that the treatment reduced hepatitis D virus levels in patients with chronic hepatitis delta. The results could support further development of the experimental medicine.
Brelovitug Targets Hepatitis B Protein
Brelovitug is a monoclonal antibody designed to target the hepatitis B surface antigen. This protein sits on the surface of the hepatitis B virus.
The drug is being developed for chronic hepatitis delta virus, also known as hepatitis D. Importantly, hepatitis D can only occur in people who already have hepatitis B.
The infection can cause serious liver problems. Over time, it may lead to significant liver damage and, in severe cases, death.
Mirum estimates that around 230,000 people in the United States and Europe are living with hepatitis delta.
Study Shows Reduction in Virus Levels
The late-stage study evaluated brelovitug at different doses. Researchers assessed patients after 24 weeks of treatment.
Among patients who received a 300-milligram dose, 56% achieved both a reduction in hepatitis D virus levels and normal liver enzyme levels.
Meanwhile, 45% of patients receiving the 900-milligram dose reached the same combined outcome.
In comparison, none of the patients in the delayed-treatment group achieved both endpoints.
These findings suggest that brelovitug may have an effect on both the virus and signs of liver inflammation. However, the complete study results have not yet been publicly presented.
Treatment Was Reported as Well Tolerated
Mirum said brelovitug was well tolerated across the dose groups. The company also reported that its safety profile remained consistent with earlier results.
Safety is particularly important for treatments aimed at chronic liver infections. Patients may need long-term care because hepatitis delta can cause progressive liver damage.
The company plans to present the complete findings at an upcoming medical congress. Therefore, additional data should provide more information about the drug’s effectiveness and safety.
FDA Submission Planned for 2027
Mirum Pharmaceuticals expects to submit a marketing application for brelovitug to the U.S. Food and Drug Administration during the first half of 2027.
For now, brelovitug remains an investigational treatment. Regulatory authorities will need to review the complete clinical evidence before deciding whether it can become an approved treatment.
If approved, the drug could add another option for people living with chronic hepatitis delta, a condition that occurs only alongside hepatitis B and can cause serious liver complications.
