Mirum Pharmaceuticals Announces Primary Endpoint Met in AZURE-4 Phase 3 Study and Highlights Long-Term Brelovitug Data Presented at AASLD
Key Highlights
- ➤AZURE-4 primary endpoint reached: 59% on brelovitug 300 mg QW versus 0% delayed treatment
- ➤AZURE-4 900 mg Q4W achieved 44% combined virologic response and ALT normalization
- ➤Cirrhosis patients reached 100% combined endpoint after up to 108 weeks of brelovitug
- ➤FDA BLA submission planned for H1 2027; potential U.S. launch targeted for Q4 2027
- ➤No new safety signals observed across AZURE-4 dose groups
Expert Statements
Nancy Shulman, Executive Vice President of Clinical Development at Mirum
“AZURE-4 marks the second U.S. registrational Phase 3 study in which brelovitug met the primary endpoint of combined virologic response and ALT normalization, demonstrating consistent efficacy in patients with substantial disease burden, including higher baseline viral loads and ALT levels.”
Nancy Shulman, Executive Vice President of Clinical Development at Mirum
“Together with the favorable safety and tolerability profiles observed across both AZURE studies and the deepening responses observed with longer-term treatment in our Phase 2 studies, we believe these results support the potential of brelovitug as a potent, single-agent treatment for chronic HDV and our planned Biologics License Application (BLA) submission in the first half of 2027.”
Tatyana Kushner, Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Weill Cornell Medicine
“Hepatitis delta is the most severe form of viral hepatitis, and many patients are living with advanced liver disease, including cirrhosis.”
Tatyana Kushner, Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Weill Cornell Medicine
“New 2026 AASLD expert opinion (EXPO) recommendations recognize that all adults with HDV viremia and compensated liver disease, including compensated cirrhosis, should be considered for HDV-specific antiviral therapy.”
Tatyana Kushner, Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Weill Cornell Medicine
“The improvements in viral suppression, ALT normalization, and liver stiffness observed with brelovitug treatment are encouraging for patients facing significant risk of disease progression.”
Mirum Pharmaceuticals Announces Primary Endpoint Met in AZURE-4 Phase 3 Study and Highlights Long-Term Brelovitug Data Presented at AASLD
– Phase 3 AZURE-4 primary endpoint of combined virologic response and ALT normalization at Week 24 achieved by 59% with brelovitug 300 mg once weekly
Get started
Create a free account to read the full story.