Survodutide shows breakthrough in liver fibrosis without worsening MASH in 64.5% of F2/F3 patients

Zealand Pharma A/S (Nasdaq: ZEAL) has reported promising findings from a Phase 2 trial of survodutide, conducted by Boehringer Ingelheim, targeting metabolic dysfunction-associated steatohepatitis (MASH). The trial's sub-analysis reveals significant improvements among adults with moderate to advanced liver fibrosis (F2 and F3 stages). Remarkably, 64.5% of these patients saw fibrosis improvement without a deterioration of MASH symptoms, compared to 25.9% in the placebo group after 48 weeks of treatment. This represents a response difference of 38.6%, with statistical significance (p=0.0005).

These findings were disclosed at the 2024 European Association for the Study of the Liver Congress (EASL) and simultaneously published in The New England Journal of Medicine. The secondary endpoint data also indicated that 52.3% of adults with mild to moderate and advanced fibrosis stages (F1, F2, and F3) experienced significant fibrosis improvement, compared to 25.8% with the placebo after 48 weeks, with a response difference of 26.5% (p<0.01).

Earlier in the year, the trial's primary endpoint results were announced, demonstrating that up to 83.0% of adults achieved statistically significant improvements in MASH compared to 18.2% in the placebo group, underscoring the potential of survodutide as a leading treatment for MASH. The response difference was 64.8%, with high statistical significance (p<0.0001).

Dr. David Kendall, Chief Medical Officer of Zealand Pharma, expressed excitement about the Phase 2 results, emphasizing survodutide's potential as a differentiated incretin-based treatment for both obesity and MASH. He highlighted that the drug will proceed to Phase 3 trials, reflecting its potential to offer substantial clinical benefits across cardiovascular, renal, and metabolic health.

The trial also confirmed the safety profile of survodutide, consistent with GLP-1 based treatments, and no new safety concerns emerged.

Survodutide, a glucagon/GLP-1 receptor dual agonist, is crucial in regulating metabolic functions. Licensed to Boehringer Ingelheim from Zealand Pharma, Boehringer manages its global development and commercialization, while Zealand retains co-promotion rights in Nordic countries. The drug received U.S. FDA Fast Track Designation in May 2021 for treating MASH and fibrosis and entered the EMA PRIME scheme in November 2023. It is also under evaluation in five Phase 3 trials for overweight and obesity, conditions often linked to MASH.

Zealand Pharma, a biotechnology company founded in 1998 and headquartered in Copenhagen, Denmark, focuses on developing peptide-based medicines. It has advanced over ten drug candidates into clinical development, with two reaching the market and three in late-stage development. Zealand collaborates with multiple pharmaceutical companies for development and commercial partnerships.