Boehringer, Zealand heat up MASH race with strong Phase II data
Boehringer, Zealand heat up MASH race with strong Phase II data
Published: Jun 07, 2024
By Tristan Manalac
BioSpace
Boehringer Ingelheim and Zealand Pharma on Friday unveiled Phase II findings for their investigational GLP-1/glucagon receptor dual agonist survodutide, which significantly improved liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis.
After 48 weeks of treatment, survodutide improved liver scarring in 52.3% of patients with mild (F1) to moderate (F2) or advanced (F3) fibrosis, compared to only 25.8% in the placebo group. The treatment effect of 26.5% was statistically significant, with a p-value less than 0.01.
Additionally, 64.5% of patients with F2 or F3 fibrosis saw improvement in liver scarring without worsening of metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% of those in the placebo group. The treatment response was 38.6%, which was highly statistically significant, according to the announcement.
The partners presented the results on Friday at the 2024 Congress of the European Association for the Study of the Liver and simultaneously published them in The New England Journal of Medicine.
Carinne Brouillon, head of human pharma at Boehringer Ingelheim, called Friday’s readout “breakthrough fibrosis results” which “reinforce survodutide’s potential as a best-in-class treatment for people living with MASH.” Boehringer Ingelheim, which is responsible for survodutide’s development and commercialization globally, will work to advance the candidate into Phase III trials “quickly,” Brouillon said.
Originally discovered and developed by Zealand, survodutide is a dual agonist of the GLP-1 and glucagon receptors, which are important in the regulation of metabolism. This dual-receptor mechanism could give survodutide the edge over currently available single-hormone agonists.
Survodutide is licensed to Boehringer from Zealand. In exchange, Zealand is eligible for milestone payments and high-single to low-double digit royalties on global sales.
In addition to MASH, Boehringer is also studying survodutide in obesity. A June 2023 readout showed that the candidate could cut body weight by around 20%. The pharma is now running the Phase III SYCHRONIZE development program, consisting of five late-stage trials. Three studies—SYNCHRONIZE-1, SYNCHRONIZE-2 and SYNCHRONIZE-CVOT—were launched in May 2023.
Friday’s readout follows a previous Phase II data drop for survodutide in MASH. Released in February 2024, the mid-stage results showed that 83% of patients saw significant biopsy-proven improvement in MASH, without fibrosis worsening. Only 18.2% of placebo comparators achieved this endpoint.
With these latest data for survodutide, Boehringer and Zealand are heat up their competition with Eli Lilly, which earlier this week revealed that its best-selling GLP-1/GIP dual receptor agonist tirzepatide can also significantly improve fibrosis in MASH patients. At a 5-mg dose, tirzepatide reduced fibrosis by at least one stage in 54.9% of patients after 52 weeks of treatment. Patients also lost around 17% of their body weight.
Source: BioSpace
