Mirum’s brelovitug meets Phase 3 primary endpoint in hepatitis delta

Mirum Pharmaceuticals says brelovitug met the primary endpoint in the Phase 3 AZURE-1 trial for chronic hepatitis delta (HDV), a serious liver infection. The company acquired the drug through its purchase of Bluejay Therapeutics.

At week 24, the combined endpoint—viral response plus normalization of ALT, a marker of liver inflammation—was reached by 56% of patients receiving 300 mg weekly and 45% receiving 900 mg every four weeks, compared with 0% in the delayed-treatment group. Both comparisons were statistically significant (p<0.0001).

The study enrolled 153 treatment-naive patients. Brelovitug was described as well tolerated, with a safety profile consistent with earlier AZURE-1 results.

The result advances Mirum’s effort to develop a treatment for HDV. It is still investigational, so the trial success is not an approval; the company has discussed a potential U.S. filing in the first half of 2027. Results from the separate Phase 3 AZURE-4 study were expected later in 2026.