Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and Obesity

Company announcement – No. 21/ 2021

Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and Obesity

• New studies mark an important advancement of Boehringer Ingelheim’s cardiometabolic focus areas obesity and NASH.
• The GLP-1/glucagon dual agonist BI 456906 may offer important benefits on both chronic weight management and NASH improvement.
• The Phase 2 trials for BI 456906 in obesity and NASH are part of the long-term collaboration between Boehringer Ingelheim and Zealand Pharma, with a prior Phase 2 trial of BI 456906 in people with type 2 diabetes initiated in 2020.

Ingelheim, Germany and Copenhagen, Denmark, 13 April, 2021 – Boehringer Ingelheim and Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) announced the initiation of two Phase 2 trials of the GLP-1/glucagon dual agonist BI 456906 for adults who are overweight or obese and for adults with non-alcoholic steatohepatitis (NASH). The compound was in-licensed from Zealand in 2011 and is being investigated in an ongoing Phase 2 study in people with type 2 diabetes mellitus. The once-weekly therapy may offer additional benefits on both chronic weight management, and NASH improvement and prevention of the progression to cirrhosis compared to currently available treatments with mono GLP-1 agonist compounds. BI 456906 is part of Boehringer Ingelheim’s growing portfolio in the obesity and NASH disease areas.

“Obesity and NASH are areas of high unmet medical need, with limited approved treatments currently available. They are associated with lower quality of life and increased mortality,” explains Prof. Arun J. Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine in Richmond, Virginia. “I hope that this new approach will bring a much-needed treatment option for HCPs and people afflicted with obesity or NASH.”

Boehringer Ingelheim and Zealand have a fruitful longstanding partnership, bringing together Zealand’s expertise in the discovery of innovative peptide-based medicines with Boehringer Ingelheim’s expertise in the research and development of novel medicines for cardiometabolic diseases. “We are very excited to see the initiation of Phase 2 trials of BI 456906 for obesity and NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining GLP-1 and glucagon agonism mechanistically, we believe our dual agonist has the potential to achieve increased weight loss, via improvement of the patient’s metabolism, and also has potential to alleviate NASH by reducing upstream steatosis.”