Boehringer rushes survodutide into late-stage development for MASH as positive data build
07 Jun 2024
Phase 2Clinical ResultPhase 3
Boehringer Ingelheim will advance the glucagon/GLP-1 receptor dual agonist survodutide into Phase III development for metabolic dysfunction-associated steatohepatitis (MASH) after disclosing further mid-stage data at the European Association for the Study of the Liver (EASL) congress. Carinne Brouillon, the company’s head of human pharma, said the results – officially announced Friday after being inadvertently released early by the EASL – “reinforce survodutide’s potential as a best-in-class treatment for people living with MASH.”
The drugmaker, which is co-developing survodutide with Zealand Pharma, reported in February that the Phase II study hit its primary endpoint, demonstrating that up to 83% of adults with MASH who were given the experimental drug achieved a significant histological improvement of their condition without worsening of fibrosis versus placebo.
At the time, Boehringer noted that the trial also met key secondary goals, including a significant improvement in liver fibrosis, without providing specific data. Results now presented at EASL, and also published in The NEJM, showed that up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH. In addition, a sub-analysis showed that up to 64.5% of adults with fibrosis stages F2 and F3 achieved an improvement in fibrosis without worsening of MASH.
Principal investigator Arun Sanyal remarked “these data position survodutide as a leading glucagon/GLP-1 receptor dual agonistGLP-1 receptor dual agonist that could be a game-changer for people living with MASH and clinically significant fibrosis.”
More to come.
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