Boehringer licenced survodutide, a dual agonist of glucagon-like peptide-1 (GLP-1) and glucagon receptors, from Zealand Pharma in 2011. Image credit: nitpicker / Shutterstock.

Boehringer Ingelheim has received a breakthrough therapy designation from the US Food and Drug Administration (FDA) for survodutide as a treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis.

Concurrently, the company also started two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, evaluating the therapy in patients with MASH with associated moderate or advanced fibrosis and cirrhosis, respectively. The FDA issues breakthrough designations to expedite certain therapies’ evaluation and review processes based on early clinical evidence.

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The MASH therapies have seen an increased interest in recent months. In March, the FDA approved the first-ever MASH therapy, Madrigal Pharmaceuticals’ Rezdiffra (resmetirom). GlobalData estimates the MASH market to reach sales of $25.7bn in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan).

GlobalData is the parent company of Clinical Trials Arena.

Survodutide is a dual agonist of glucagon-like peptide-1 (GLP-1) and glucagon receptors. In 2011, Boehringer licensed the therapy from Zealand Pharma. The companies first developed survodutide as a treatment for type 2 diabetes and obesity. Boehringer has sole development and commercialisation rights to the therapy globally, except in Nordic countries where it shares the marketing rights with Zealand Pharma.

The placebo-controlled Phase III LIVERAGE trial is expected to enrol about 1,800 patients with MASH and moderate or advanced (stage II-III) fibrosis. The study will be divided into two parts – part one consisting of 52 weeks and a follow-on part two continuing to seven years.

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The primary endpoints in part one will evaluate what proportion of patients achieve MASH resolution without worsening of fibrosis, and at least a one-point improvement in fibrosis without worsening of MASH, after 52 weeks of treatment. The primary endpoint of part two is the time to first occurrence of liver-related events or all-cause mortality.

The placebo-controlled Phase III LIVERAGE-Cirrhosis will enrol about 1,590 participants with MASH and stage 4 liver cirrhosis. The study’s primary endpoint is the time to the first occurrence of all-cause mortality or liver-related events across 4.5 years.

Survodutide’s main competitor is expected to be Eli Lilly’s tirzepatide, which has shown positive results in a Phase II MASH trial. GlobalData expects Lilly’s therapy to benefit from significant physician familiarity as it has already been approved and marketed as Mounjaro and Zepbound for treating type 2 diabetes and obesity, respectively.