Up to 83.0% of adults treated with survodutide (Boehringer Ingelheim and Zealand Pharma) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2 trial [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring). Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis.
The double-blind, placebo-controlled Phase 2 trial studied three doses of survodutide at 2.4mg, 4.8mg and 6.0mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial. Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0mg.
Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action that activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. Survodutide was co-invented by Boehringer Ingelheim and Zealand Pharma. Survodutide has received FDA Fast Track Designation for the treatment of MASH and fibrosis. Survodutide is also being evaluated in five Phase 3 trials as part of the SYNCHRONIZE clinical programme for people living with overweight and obesity.
"We are very excited by the positive topline Phase 2 trial results for survodutide in MASH announced today by Boehringer Ingelheim and we look forward to the planned disclosure of the full data at a scientific congress in the first half of this year," said Dr David Kendall, Chief Medical Officer of Zealand Pharma. "Furthermore, we are delighted with the announcement that Boehringer intends to move forward with further development in MASH as quickly as possible, as they progress with study recruitment in the ongoing Phase 3 clinical trial program for obesity."
The company also announced that full data from this study will be presented in the coming months.