Liver fibrosis significantly improved in patients with metabolic dysfunction-associated steatohepatitis (MASH) in Boehringer Ingelheim’s Phase II trial of survodutide, without exacerbating the underlying condition. According to the company, survodutide also exhibited a clinically meaningful improvement in liver scarring across all stages of fibrosis (F1 to F3) when compared to a placebo. Notably, survodutide is the first glucagon/GLP-1 receptor dual agonist to show such promising results in this domain.
Dr. Arun Sanyal, a professor of medicine, physiology, and molecular pathology at Virginia Commonwealth University School of Medicine and the principal investigator of the trial, expressed his enthusiasm about the findings. He stated, “I am particularly excited about the findings of the Phase II trial in survodutide, which demonstrate the potential for glucagon agonism, in addition to GLP-1, to both improve MASH and shift the needle on fibrosis. These data position survodutide as a leading glucagon/GLP-1 receptor dual agonist that could be a game-changer for people living with MASH and clinically significant liver fibrosis.”
The Phase II trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of weekly subcutaneous injections of survodutide in 295 participants living with MASH and liver fibrosis (F1, F2, and F3). The primary endpoint of the trial was the number of patients achieving histological improvement of MASH without worsening fibrosis after 48 weeks of treatment. Secondary endpoints included a minimum of 30% relative reduction in liver fat content after 48 weeks, either complete or relative reduction in liver fat content, improvement of liver fibrosis, and a complete change from baseline in the total score for MASH after 48 weeks.
Survodutide Phase II Trial Shows Significant Improvement in Liver Fibrosis and Fat Reduction
The trial results were highly encouraging. Up to 64.5% of patients with moderate to advanced scarring experienced an improvement in liver fibrosis without worsening MASH, compared to 25.9% in the placebo group after 48 weeks of treatment. Additionally, about 52.3% of adults treated with survodutide showed significant improvement in liver scarring across all three stages of liver fibrosis, compared to 25.8% in the placebo cohort. Furthermore, around 87% of patients in the survodutide arm achieved at least a 30% relative reduction in liver fat, compared to 19.7% in the placebo group. The relative reduction in liver fat content reached up to 64.3% with survodutide, compared to 7.3% with placebo.
Safety results from the trial were consistent with those typically observed with GLP-1-based molecules, and no new safety concerns were reported. In 2021, survodutide received Fast Track Designation from the U.S. Food and Drug Administration (FDA) and Priority Medicine Scheme designation from the European Medicines Agency (EMA). The full results of the current data were presented at the European Association for the Study of the Liver Congress and published in The New England Journal of Medicine.
Survodutide Advances to Phase III Trials with Promising Results for Liver Fibrosis in MASH Patients
Survodutide is currently undergoing additional testing in five different Phase III studies targeting patients who are overweight or struggling with obesity, a two-part Phase I trial in cirrhosis and liver dysfunction, and a Phase III trial to determine whether it can effectively reduce liver fat and promote weight loss in people living with overweight or obesity and a confirmed or presumed diagnosis of MASH.
Carinne Brouillon, head of Human Pharma at Boehringer Ingelheim, emphasized the significance of these findings in a press release. She stated, “These breakthrough fibrosis results further reinforce survodutide’s potential as a best-in-class treatment for people living with MASH. We will advance quickly into Phase III trials. New treatments are urgently needed for MASH, a disease connected with cardiovascular, renal, and metabolic conditions like obesity, and we are excited to continue these important discussions with healthcare authorities.”
The promising results from this Phase II trial suggest that survodutide could become a leading treatment option for patients suffering from MASH and liver fibrosis, offering hope for improved outcomes in this challenging condition. As the drug moves into Phase III trials, the medical community remains optimistic about its potential to transform the treatment landscape for MASH and related metabolic disorders.
Resource: Boehringer İngelheim, June 07, 2024
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