Mirum’s brelovitug meets primary endpoint in hepatitis delta trial
FOSTER CITY, Calif. - Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) announced today that brelovitug met the primary endpoint in the Phase 3 portion of its AZURE-1 study for chronic hepatitis delta virus treatment, according to a press release statement.
At Week 24, 56% of patients receiving brelovitug 300 mg once weekly and 45% receiving 900 mg once every four weeks achieved the combined endpoint of virologic response and ALT normalization, compared to 0% in the delayed treatment arm (p<0.0001 for both comparisons). The Phase 3 portion enrolled 153 treatment-naive patients randomized in a 2:2:1 ratio across the three arms.
Virologic response rates reached 86% in the 300 mg arm and 85% in the 900 mg arm. ALT normalization occurred in 63% and 54% of patients in the respective dose groups. Among patients achieving virologic response, 25% and 26% reached HDV RNA below the lower limit of quantification, while 17% in each arm achieved target not detected status.
The 48-week data from the Phase
