Zealand Pharma A/S announced that an embargoed abstract of positive results from Boehringer Ingelheim's Phase 2 trial of survodutide (BI 456906) in metabolic dysfunction-associated steatohepatitis (MASH) due to be presented at the European Association of the Study of Liver Congress (EASL) 2024 on June 7 was intentionally and temporarily made available through the congress website. The announcement follows topline data announced earlier 2024 (Company announcement 8/2024) that the double-blind, placebo-controlled Phase 2 trial investigating three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg met its primary endpoint of histological improvement of MASH without worsening of fibrosis after 48 weeks. The new results in the abstract include a key secondary endpoint of improvement in fibrosis (=1 stage decrease) without worsening of MASH, confirming highly statistically significant and clinically relevant reductions in liver scarring (fibrosis) stages F1, F2 and F3 (mild to moderate or advanced scarring) with survodutide.

In this trial, survodutide demonstrated safety data consistent with GLP-1 based molecules, with no new safety data concerns.