Boehringer, Zealand GLP-1 MASH Data Accidentally Published by Medical Congress Website

Zealand Pharma announced on Thursday that a medical congress had "unintentionally and temporarily" made public data from a Phase II clinical trial of survodutide, a liver disease drug developed in partnership with Boehringer Ingelheim. The data was intended to be presented at the European Association for the Study of Liver Congress (EASL) on Friday. However, the information was disclosed prematurely, violating EASL's embargo. Zealand confirmed that the abstract has since been removed from public access.

Although Zealand did not disclose specific data from the trial in its announcement, it did provide an overview of the findings that will be presented at EASL. The new data indicate that the trial achieved a secondary endpoint, demonstrating an improvement in fibrosis without aggravating metabolic dysfunction-associated steatohepatitis (MASH). This is a critical efficacy measure sought by the FDA in pivotal studies.

The study revealed substantial reductions in fibrosis among patients with varying degrees of liver scarring. Additionally, the safety profile was consistent with that of GLP-1 based treatments. Currently, Eli Lilly and Novo Nordisk dominate the GLP-1 market with their products Mounjaro (tirzepatide) and Ozempic (semaglutide), respectively. However, they may face increased competition from other companies in the near future.

Boehringer Ingelheim licensed survodutide in 2011 and has since launched an extensive clinical development initiative, including five Phase III trials focusing on individuals with overweight and obesity issues. They are also advancing survodutide in MASH, influenced by the positive Phase II data. Boehringer released topline results from the mid-phase study in February 2024 and will provide a detailed analysis at the EASL event on Friday.

In their Thursday statement, Zealand executives mentioned that they were seeing the trial data for the first time. The company clarified that, prior to the unintended EASL disclosure, they had not received any information regarding the results.

Zealand maintains that survodutide offers advantages in treating MASH that surpass the effects of GLP-1 molecules like tirzepatide and semaglutide. Eli Lilly and Novo Nordisk are investigating whether GLP-1-induced weight loss can enhance MASH outcomes. Survodutide is theorized to combine the weight loss benefits of GLP-1 drugs while also modifying the metabolism of free fatty acids by targeting the glucagon receptor.

The accidental release of MASH data is reminiscent of a similar incident involving Roche's anti-TIGIT antibody tiragolumab last year. In that case, Roche inadvertently published the results on its website, which were subsequently noticed by Wall Street analysts.

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