Boehringer, Zealand’s GLP-1 MASH Data ‘Unintentionally’ Published by Medical Congress Website
Clinical ResultPhase 2Phase 3
Pictured: Boehringer Ingelheim's office in California/iStock, Sundry Photography
Zealand Pharma said Thursday a medical congress had “unintentionally and temporarily” published data from a Phase II clinical trial of its Boehringer Ingelheim-partnered liver disease drug survodutide.
Researchers are scheduled to present data on the glucagon/GLP-1 receptor dual agonist at the European Association of the Study of Liver Congress (EASL) Friday. However, EASL seemingly broke its own embargo, as Zealand said in its statement about the disclosure of the metabolic dysfunction-associated steatohepatitis (MASH) data.
With the abstract now offline again, Zealand did not share any data from the trial in its statement but did provide a high-level look at new results that researchers will present at EASL. The new results show the trial met a secondary endpoint that looked at improvement of fibrosis without worsening of MASH, one of the efficacy measures that the FDA wants to see in pivotal studies.
Zealand said the trial confirmed significant reductions in fibrosis in people with mild to advanced scarring and generated safety data consistent with GLP-1 based molecules. Eli Lilly and Novo Nordisk, which respectively sell Mounjaro (tirzepatide) and Ozempic (semaglutide), are leading the GLP-1 space but may face competition from other companies in the coming years.
Boehringer licensed survodutide from 2011 and has initiated a broad clinical development program that includes five Phase III trials in people living with overweight and obesity. The company is also advancing survodutide in MASH after seeing Phase II data. Boehringer reported topline results from the mid-phase study in February 2024 and will provide a closer look at the data at EASL Friday.
In Thursday’s announcement, Zealand executives said they were among the people seeing the data for the first time. According to the company, prior to learning of the unintentional EASL disclosure, it had “received no information about the results.”
Zealand has said survodutide can provide benefits in MASH that go beyond the effect of pure GLP-1 molecules such as tirzepatide and semaglutide. Lilly and Novo are working to show if GLP-1-driven weight loss improves outcomes in MASH. In theory, survodutide can provide the weight loss of GLP-1 drugs while also altering the metabolism of free fatty acids by targeting the glucagon receptor.
The unintentional release of the MASH results is reminiscent of the “inadvertent disclosure” of data on Roche’s anti-TIGIT antibody tiragolumab last year. In that case, Roche accidentally published the results on its own website, where they were seen by Wall Street analysts.
Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.
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