German drugmaker Boehringer Ingelheim will initiate Phase 2 clinical trial of dual-acting GLP-1/glucagon agonist BI 456906 in obesity and diabetes in late 2019.

The compound in-licensed from Zealand Pharma is derived from the natural gut hormone oxyntomodulin and activates both the GLP-1 and glucagon receptors to control metabolic activities.

The dual agonist BI 456906 with potential for once-weekly administration is part of Boehringer Ingelheim’s pipeline portfolio in obesity and diabetes.

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

Boehringer Ingelheim to initiate phase 2 clinical trial of BI 456906 in obesity, diabetes. Photo courtesy of Madras150/Wikimedia Commons.

Emmanuel Dulac – president and CEO, Zealand Pharma said: “We believe that BI 456906 has great therapeutic potential, and we are thrilled to see it advance into Phase 2 development.

“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.”

Of the €365 million in outstanding milestone payments and high single to low double-digit royalties on global sales, Zealand Pharma will receive €20 million milestone payment with the initiation of BI 456906 Phase 2 trial.

Clive R Wood – senior corporate vice president, Discovery Research, Boehringer Ingelheim said: “We are excited to see this candidate from our dedicated and productive long-term collaboration with Zealand Pharma proceed to the next stage of clinical studies

“This brings us an important step further to bringing BI 456906 to the many patients that are in need of new treatment options.”

Zealand Pharma has licensed two product candidates to Boehringer Ingelheim, which funds all research, development and commercialization activities.

The Danish drug maker will receive up to €283 million in outstanding milestone payments, and mid-single digit to low-double digit percentage royalties on global sales for the other collaboration compound, a long-acting amylin analog.

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