Company: MIRM
Filing Date: 2025-12-08
Form Type: 8-K
Source: 0001193125-25-310611
Chunk: 2

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-12-08
Form: 8-K
Item: Item 7.01
Chunk 2
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 potential patent term extension.

HDV, a coinfection that occurs in some people infected with the hepatitis B virus, is the most severe form of viral hepatitis due to the potential for rapid progression to liver cirrhosis, liver cancer and liver-related death. HDV is believed to infect approximately 40,000 people in the United States, more than 230,000 people in the United States and Europe and more than 12 million people worldwide, with approximately 15,000 estimated U. S. patients currently diagnosed, insured and under care for HDV. The Company estimates a worldwide total annual revenue potential of brelovitug in HDV to be more than $750 million. The Company estimates that, without new treatments, more than 50% of individuals with HDV will die of liver-related causes within 10 years of diagnosis due to rapid progression to fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer with the average progression to cirrhosis and liver failure being approximately five years and the risk of liver cancer for patients with HDV being approximately three times greater than for patients with HBV. There are currently no approved treatments for HDV in the United States.

Brelovitug is being evaluated in the AZURE Phase 3 global, registrational program for HDV, which program includes four open-label studies designed to assess the primary endpoint of combined virologic and biochemical response: AZURE 1 and AZURE 4, which are intended to enable a regulatory filing with the FDA, and AZURE 2 and AZURE 3, which are intended to support a regulatory filing with the EMA. The AZURE Phase 3 studies build on the Phase 2 studies where brelovitug demonstrated strong antiviral activity in HDV, achieving 100% HDV ribonucleic acid response along with improvements in alanine aminotransferase enzyme levels and a favorable safety profile, with the most common adverse event being injection-site erythema. The ongoing global AZURE Phase 3 program is currently enrolling patients, with an interim analysis of AZURE 1 expected in the second quarter of 2026, top-linedata from AZURE 1 and AZURE 4 expected in the second half of 2026 and top-linedata from AZURE 2 and AZURE 3 expected by the first half of 2028. The Company believes that these results may support a potential biologics license application submission to the FDA for brelov