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Mirum Pharmaceuticals Announces Primary Endpoint Met in AZURE-4 Phase 3 Study and Highlights Long-Term Brelovitug Data Presented at AASLD

MIRM
  • Phase 3 AZURE-4 study met its primary endpoint at Week 24, with 59% of patients receiving brelovitug 300 mg once weekly achieving combined virologic response & ALT normalization.
  • Brelovitug 300 mg once weekly showed 100% virologic response & 100% ALT normalization in patients with cirrhosis after up to 108 weeks of treatment.
  • A favorable safety & tolerability profile was observed across all studies with no new safety signals identified.
  • The most common adverse event was flu-like illness, occurring in 17.2% of patients on the 300 mg dose & 18.5% on the 900 mg dose.
  • Mirum Pharmaceuticals plans to submit a Biologics License Application (BLA) to the U.S. FDA in the first half of 2027.
  • Brelovitug is an investigational fully human monoclonal antibody targeting hepatitis B surface antigen (HBsAg) for the treatment of chronic hepatitis delta virus (HDV).
  • AZURE-4 enrolled 113 treatment-naïve patients, 53% of whom had cirrhosis & approximately half had baseline HDV RNA levels exceeding 6 log10 IU/mL.
  • No patients in the delayed-treatment arms of AZURE-1 or AZURE-4 studies achieved the primary combined endpoint.
  • Data presented at The Liver Meeting® demonstrated deepening viral suppression, increased ALT normalization rates, & improvements in liver stiffness with longer treatment duration.
  • Mirum aims for a potential U.S. commercial launch in the fourth quarter of 2027 if the drug receives regulatory approval.