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Zealand Pharma and Boehringer Ingelheim initiate Phase 2 development of BI 456906

Emmanuel Dulac

Boehringer Ingelheim plans to initiate Phase 2 development of the GLP-1/glucagon dual agonist BI 456906, which  was in-licensed from Zealand.

Boehringer Ingelheim and Zealand have a longstanding partnership, bringing together Zealand’s expertise in the discovery of peptide-based medicines with Boehringer Ingelheim’s expertise in the research and development of novel medicines for cardiometabolic diseases.

Potential as a new, once-weekly treatment that may offer therapeutically relevant benefits

The compound derived from the natural gut hormone oxyntomodulin activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has potential as a new, once-weekly treatment that may offer therapeutically relevant benefits compared to currently available treatments. It is part of Boehringer Ingelheim’s growing research and development stage portfolio in the obesity and diabetes disease areas.

The decision to advance BI 456906 to Phase 2 clinical testing is based on the safety and tolerability and the favorable weight loss potential in individuals with a BMI up to 40 kg/m2. The Phase 2 trial will be a dose-finding, placebo and active comparator clinical proof of concept trial in patients with obesity and type 2 diabetes.

“We believe that BI 456906 has great therapeutic potential, and we are thrilled to see it advance into Phase 2 development,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “Our strong partnership with Boehringer Ingelheim unites expertise and capabilities to achieve a shared vision of helping millions of people better manage and overcome obesity and type 2 diabetes.”

Zealand has licensed two product candidates

Zealand has licensed two product candidates to Boehringer Ingelheim, both with potential for once-weekly administration. Under the terms of the two agreements, Boehringer Ingelheim funds all research, development and commercialization activities. For the GLP1/glucagon dual agonist, Zealand is entitled to receive up to EUR 365 million in outstanding milestone payments and will receive a milestone payment of EUR 20 million related to initiation of Phase 2.

The agreement also carries high-single digit to low-double digit percentage royalties on global sales. The other collaboration compound is a long-acting amylin analog for which Zealand is entitled to receive up to EUR 283 million in outstanding milestone payments, and mid-single digit to low-double digit percentage royalties on global sales.

Photo of Emmanuel Dulac, CEO, Zealand Pharma