Drugs and FDA
Mirum reports phase 3 success for chronic hepatitis D treatment
At Week 24, the combined response endpoint was met by 56% of patients on 300 mg, 45% on 900 mg and 0% in the delayed-treatment arm.
Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial of brelovitug for chronic hepatitis delta virus met its primary endpoint. At Week 24, both dosing regimens beat the delayed-treatment control arm.
The endpoint combined virologic response and normalization of ALT, a marker of liver inflammation. Response rates were 56% with 300 mg once weekly, 45% with 900 mg every four weeks and 0% in the control arm. About 85% of patients receiving brelovitug had a virologic response.
Mirum expects to share phase 3 results from another trial, Azure-4, in the fourth quarter. If that trial hits, the company could seek FDA approval in the first half of next year and bring brelovitug to market by the end of 2027.
