Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

Boehringer Ingelheim and Zealand Pharma announced on June 2, 2021 that FDA has granted fast track designation to BI 456906, an investigational glucagon-like peptide 1 (GLP-1)/glucagon dual agonist, for the treatment of non-alcoholic steatohepatitis (NASH). BI 456906 is currently in a Phase II study in adults with NASH and liver fibrosis with and without diabetes.

GLP-1/glucagon is a compound derived from oxyntomodulin, a natural gut hormone, that activates both the GLP-1 and glucagon receptors critical for controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new, once-weekly treatment and is also being investigated as a potential treatment for adults with diabetes and for adults with obesity.

“The FDA [f]ast [t]rack [d]esignation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, corporate vice-president and head of CardioMetabolic Medicine, Boehringer Ingelheim, in a company press release. “Together with our partner Zealand Pharma, we look forward to working closely with [FDA] as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.”

“Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH,” said Adam Steensberg, executive vice-president and chief medical officer at Zealand Pharma, in the press release. “By combining Boehringer Ingelheim’s expertise in drug development in the cardio-metabolic area with our strength in the discovery of innovative peptide-based medicines, we have the potential to bring forward a novel therapy option in an area with limited available treatments.”

Source: Boehringer Ingelheim