Mirum’s hepatitis-delta drug succeeds in Phase 3 AZURE-1

Mirum Pharmaceuticals ($MIRM) said brelovitug met the primary endpoint in the Phase 3 portion of AZURE-1, which enrolled 153 treatment-naive patients with chronic hepatitis delta. At 24 weeks, the combined viral-response and liver-enzyme-normalization endpoint was achieved by 56% receiving 300 mg weekly and 45% receiving 900 mg every four weeks, versus 0% in the delayed-treatment group. Both comparisons were statistically significant.

The findings advance one of the two pivotal studies intended to support a U.S. registration package. Mirum reported no new safety signals and expects results from the second study, AZURE-4, in the fourth quarter, followed by a filing in the first half of 2027. Those milestones remain prospective: the reported endpoint does not establish a cure or amount to regulatory approval.

Sources:

• Mirum company release — Business Wire
• Timestamped distribution