Boehringer to present mid-stage MASH trial results after 'unintentional' release

2024-06-06

临床结果临床2期上市批准临床3期

Boehringer Ingelheim will present positive results from a phase 2 trial of survodutide in metabolic dysfunction-associated steatohepatitis (MASH) at the European Association of the Study of Liver Congress, after the embargoed abstract was accidentally made public.

According to a press release from Zealand Pharma, the company licensing the drug to Boehringer, the abstract was "unintentionally and temporarily made available through the congress website." It has since been removed.

The topline data from the double-blind trial was announced earlier this year, demonstating that 83% of adults treated with survodutide achieved groundbreaking results in liver disease due to MASH, with significant improvements in liver fibrosis (scarring).

According to Zealand, the new results in the abstract include a key secondary endpoint of improvement in fibrosis without worsening of MASH, confirming "highly statistically significant reductions in fibrosis with survodutide.

Survodutide, co-invented by Boehringer Ingelheim and Zealand Pharma, is a glucagon/GLP-1 receptor dual agonist GLP-1 receptor dual agonist with a novel mechanism of action that activates both the GLP-1 and glucagon receptors. It's being evaluated in five phase 3 trials for people living with overweight and obesity, but the partners are betting on it becoming a best-in-class treatment for MASH/NASH.

An advanced form of nonalcoholic fatty liver disease, MASH/NASH is a leading cause of liver-related mortality, affecting approximately 1.5 million people in the U.S. The past March, Madrigal Pharmaceuticals won the first FDA approval for a MASH treatment for its a once-daily, oral THR-β agonist THR-β agonist, Rezdiffra.

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