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

INGELHEIM, Germany & COPENHAGEN, Denmark–()–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.”

Our cardiometabolic research and development is focusing on discovering novel treatments for obesity and non-alcoholic steatohepatitis (NASH), to meet the large unmet need among these groups,” explains Waheed Jamal, MD, Head of Cardiovascular, Metabolic and Respiratory Medicine at Boehringer Ingelheim. “We are exploring a number of unique approaches with great potential to help people living with obesity or NASH. We believe dual agonists are next generation drug candidates with a potential for higher efficacy in weight loss and NASH improvement/cirrhosis prevention.”

Under the terms of the GLP-1/glucagon dual agonist licensing agreement, Boehringer Ingelheim funds all research, development and commercialization activities. Zealand is entitled to receive up to EUR 345 million in outstanding milestone payments. No milestone payments are due with the initiations of these Phase 2 studies. The agreement also carries high-single digit to low-double digit percentage royalties on global sales.

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