Survodutide Phase II Success: 83% MASH Liver Disease Improvement with Enhanced Fibrosis Outcomes

A recent study has indicated that a drug named survodutide (BI 456906) has shown significant promise in treating a liver condition known as metabolic dysfunction-associated steatohepatitis (MASH), previously referred to as NASH. In a Phase II trial, survodutide outperformed placebo, achieving a marked improvement in MASH in 83.0% of adults, compared to 18.2% in the placebo group. This advancement is notable as MASH is a severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), which is projected to become the primary cause of liver transplants by 2030.

The trial was a double-blind, placebo-controlled investigation involving 295 participants with MASH and varying degrees of liver fibrosis. It aimed to evaluate the efficacy of weekly subcutaneous injections of survodutide. The primary goal was to observe the histological improvement in MASH without an escalation in fibrosis stages after 48 weeks of treatment. The study also examined secondary outcomes, such as changes in liver fat content and fibrosis levels.

Survodutide functions as a dual agonist of the glucagon and GLP-1 receptors, which play a crucial role in metabolic regulation. The drug has been co-developed by Boehringer Ingelheim and Zealand Pharma, with the potential to increase energy expenditure and directly impact liver health, contributing to fibrosis improvement.

Dr. Arun Sanyal, the principal investigator of the trial and a professor at Virginia Commonwealth University School of Medicine, expressed enthusiasm about the trial's results, highlighting survodutide's potential as a leading treatment for individuals with significant unmet medical needs.

Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim, emphasized the drug's novel mechanism of action and its potential to benefit over a billion people affected by interconnected cardiovascular, renal, and metabolic diseases.

The positive results have been supported by the FDA's Fast Track Designation and the EMA's Priority Medicine (PRIME) Scheme, both of which are designed to expedite the review of drugs addressing serious conditions with high unmet needs.

Boehringer Ingelheim is also conducting five Phase III studies for survodutide in overweight and obesity populations, including those with comorbidities and type 2 diabetes. Additionally, the company is exploring the drug's effects in Phase III trials in Japan and China.

MASH is a chronic and progressive liver disease characterized by fat accumulation in the liver, closely associated with cardiovascular, renal, and metabolic diseases. With an increasing prevalence and the potential to severely impact quality of life, the development of targeted therapies for MASH is crucial. The survodutide trial offers hope for improved treatment options in managing this condition.