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Jump to Key Points Sept 28 (Reuters) - Mirum Pharmaceuticals on Monday said its experimental hepatitis drug reduced levels of the virus in patients, meeting the main goal of a late-stage study.
Here are some key details:
• Mirum was testing brelovitug, an experimental monoclonal antibody that binds to the hepatitis B surface antigen, a protein found on the surface of the virus
• The company was testing the treatment for chronic hepatitis delta virus, a liver infection that affects people already infected with hepatitis B
- Brelovitug met primary endpoint in chronic hepatitis delta virus.
- 24 wks: 56% (300 mg) and 45% (900 mg) achieved HDV↓ + normal LFTs.
- Delayed-treatment group: 0% achieved virologic/biochemical response.
- Drug was well tolerated; safety consistent with prior data.
- FDA submission planned 1H 2027; only approved therapy is Hepcludex.
• The disease, which the company estimates affects about 230,000 people in the US and Europe, can cause severe symptoms that can lead to liver damage and, in some cases, death
• At 24 weeks, 56% of patients given 300 milligrams of brelovitug and 45% of those given 900 milligrams showed reduced hepatitis D virus levels and normal liver enzyme levels, compared with 0% in the delayed-treatment group, the company said
• The company expects the drug to generate peak sales of at least $1 billion
• The only FDA-approved treatment for the condition is Gilead's Hepcludex
• "Brelovitug has a better benefit/risk profile," said RBC Capital Markets analyst Lisa Walter, adding that the latest results position it as the best-in-class treatment option
• The drug was well tolerated across dose groups, with a safety profile consistent with previously reported data, Mirum said
• Full results from the study will be presented at an upcoming medical congress, with the company expecting to submit a marketing application for the drug to the US FDA in the first half of 2027.
(Reporting by Sneha S K in Bengaluru; Editing by Jonathan Ananda and Diti Pujara)
