Mirum's liver infection drug lowers virus levels in late-stage study

Sept 28 — 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

• 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)

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