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Part of situation: Hepatitis Delta virus treatment developments (2 clusters)

Mirum Pharmaceuticals reports positive Phase 3 results for hepatitis delta treatment

hepatitis delta virus monoclonal antibody clinical trial virologic response ALT normalization

Mirum Pharmaceuticals has announced that its investigational monoclonal antibody, brelovitug, met the primary endpoint in the Phase 3 AZURE-1 clinical trial for patients with chronic hepatitis delta virus (HDV) infection.

At week 24, the study reported that 56% of patients receiving a 300 mg weekly subcutaneous injection and 45% of patients receiving 900 mg every four weeks achieved a combined virologic response and alanine aminotransferase (ALT) normalization. In contrast, 0% of the delayed treatment group reached this endpoint.

Brelovitug targets the hepatitis B surface antigen (HBsAg). The AZURE-1 study is one of two pivotal Phase 3 trials intended to support a regulatory submission in the United States for the treatment of chronic HDV. The goal of the therapy is to control the virus and liver inflammation to prevent progression to cirrhosis, liver failure, or liver cancer.

Entities

Mirum Pharmaceuticals

Sources

Mirum Brelovitug Meets Phase 3 Goal in Hepatitis Delta [lifescivoice.com]
APEX Part B: Zumilokibart Achieves Primary Endpoint in Atopic Dermatitis | HCPLive [www.hcplive.com]
Mirum Pharmaceuticals Aktie: Kursziel auf 144 Dollar [www.ad-hoc-news.de]
Barzolvolimab Achieves All Phase 3 End Points in Chronic Spontaneous Urticaria | Dermatology Times [www.dermatologytimes.com]
Brelovitug Meets Primary Endpoint in Phase 3 AZURE-1 Hepatitis Delta Trial [www.consultantlive.com]
Mirum Pharmaceuticals, Inc. (MIRM) Discusses Topline Results from Phase III AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Transcript [seekingalpha.com]