Mirum presents new data on rare liver disease treatments at EASL congress

Mirum Pharmaceuticals Inc. (NASDAQ: MIRM) announced results from clinical studies of its rare liver disease treatments at the European Association for the Study of the Liver International Liver Congress 2026.

The company presented late-breaking results from two Phase 2b studies. The VISTAS study of volixibat in primary sclerosing cholangitis showed a 1.64-point placebo-adjusted reduction in pruritus as measured by the Adult Itch Reported Outcome scale. Fifty-six percent of patients achieved a reduction of at least 2 points in pruritus compared with 26% on placebo.

The AZURE-1 study of brelovitug for chronic hepatitis delta virus demonstrated virologic response rates of 100% in the 300 mg once weekly arm and 75% in the 900 mg once every four weeks arm at Week 24, compared to 0% in the delayed treatment arm. The primary composite endpoint of virologic response and ALT normalization was achieved in 45% and 35% of patients in the respective treatment arms versus 0% in the delayed treatment group.

Mirum also presented data on LIVMARLI (maralixibat) in progressive familial intrahepatic cholestasis. An analysis comparing patients treated with LIVMARLI to a control cohort from the NAPPED database showed improved event-free survival, with a hazard ratio of 0.29 for overall events including surgical biliary diversion, liver transplantation, or death.

The company has scheduled a pre-New Drug Application meeting with the FDA for volixibat in summer 2026, with planned NDA submission in the second half of 2026. Topline data from Phase 3 AZURE-1 and AZURE-4 studies for brelovitug are expected in the second half of 2026.

Information is based on a company press release.

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