Zealand and Roche Diabetes Care enter Phase 3 study collaboration for Treatment of CHI with Dasiglucagon
Zealand Pharma reports that it has engaged in a collaboration with Roche Diabetes Care for the Phase 3 trials with dasiglucagon for treatment of congenital hyperinsulinism (CHI). Zealand is responsible for conducting the Phase 3 trials, while Roche Diabetes Care provides its Accu-Chek Combo pump system for this study under the terms of the agreement. Together, the two companies aim to evaluate the potential for a new non-surgical treatment for children with CHI.
Britt Meelby Jensen, President and CEO of Zealand, comments: “We are pleased to work with Roche Diabetes Care products for the Phase 3 study of dasiglucagon for treatment of congenital hyperinsulinism. In the trials, neonates and children with CHI will be given low doses of dasiglucagon infused via the Accu-Chek Combo pump system. We are excited about pursuing the development of a treatment for this severe and rare disease affecting neonates and children.”
Ulf Meiertoberens, Lifecycle Leader Insulin Delivery Systems at Roche Diabetes Care, comments: “We are impressed with the progress made by Zealand with dasiglucagon, now Phase 3 ready, for the treatment of congenital hyperinsulinism and are happy to be able to contribute with our expertise and the Accu-Chek® Combo pump system, and together with Zealand evaluate this potential new therapy option for children affected by CHI.”
CHI is a rare medical condition in neonates and children. Due to a genetic defect in the insulin producing cells, these children are born with too high blood insulin levels, resulting in persistent low blood glucose throughout childhood. Current treatment options are insufficient and the most severely affected children need to have their pancreas surgically removed within the first months of life in order control the blood glucose levels.
In the Phase 3 program, Zealand will evaluate the potential of continuous dasiglucagon infusions delivered via the Accu-Chek Combo pump system to prevent hypoglycemia in up to 50 children with CHI and thereby reduce morbidities associated with persistent hypoglycemia as well as neurodevelopmental defects and need for having their pancreas surgically removed.
Dasiglucagon is a potential first-in-class glucagon analog invented and developed by Zealand. It is stable in aqueous formulation and suitable for pump use and thereby for potential treatment of CHI. In January 2018, the U.S. Food and Drug Administration (FDA) approved Zealand’s Investigational New Drug (IND) application for initiation of two Phase 3 clinical trials of dasiglucagon in CHI. This approval enables Zealand to proceed into Phase 3 development of dasiglucagon for the treatment of CHI in 2018.