Key insights
- Mirum Pharmaceuticals' brelovitug met the primary endpoint in the Phase 3 AZURE-1 study for chronic hepatitis delta virus treatment. Significant percentages of patients achieved virologic response and ALT normalization with brelovitug, with no Grade 3 or higher treatment-related adverse events. This positive outcome strengthens Mirum's development pathway for the drug.
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 2b portion, which included 53 patients, showed continued improvement. The combined endpoint increased from 45% at Week 24 to 55% at Week 48 in the 300 mg arm, and from 35% to 55% in the 900 mg arm. HDV RNA below the lower limit of quantification rose from 45% to 80% in the 300 mg group.
The treatment was well tolerated across dose groups. No Grade 3 or higher adverse events related to treatment occurred in the brelovitug arms through Week 24 in the Phase 3 portion. No participants discontinued due to adverse events in any treatment arm.
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Mirum expects topline results from its second pivotal Phase 3 study, AZURE-4, in the fourth quarter of 2026. The company plans to submit a Biologics License Application to the FDA in the first half of 2027.
Brelovitug is an investigational monoclonal antibody targeting hepatitis B surface antigen. There are currently no approved treatments for HDV in the United States.
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