Zealand pumps up its prospects with late-phase rare disease hit

Zealand Pharma has opened up a new frontier for its struggling glucagon analog dasiglucagon, linking the pump-delivered therapy to improved outcomes in kids with congenital hyperinsulinism (CHI) in a phase 3 clinical trial. 

Copenhagen, Denmark-based Zealand won FDA approval for dasiglucagon in very low blood pressure one year ago but has failed to live up to commercial expectations, leading it to lay off staff and seek partners for assets earlier this year. Zealand is seeking a partner for assets including its blood pressure drug, Zegalogue, and other late-stage clinical applications of dasiglucagon.

After running into the difficulties, the phase 3 clinical trial of dasiglucagon delivered via an infusion pump to prevent low blood sugar in children with CHI brought a rare recent piece of good news for Zealand. In the study of 12 subjects aged seven days to 12 months, Zealand linked dasiglucagon to a 55% fall in the need for intravenous glucose. 

Dasiglucagon previously failed to reduce the rate of low blood pressure in another phase 3 clinical trial. However, with the second study hitting its primary endpoint Zealand now thinks it has the data to file for FDA approval by the end of the year. The anticipated timing of the filing puts Zealand at the head of a pack of companies such as Eiger BioPharmaceuticals, Rezolute and Xinvento that are targeting CHI.

“We are extremely pleased with the top-line results from our second phase 3 study of dasiglucagon for the treatment of infants with CHI,” Zealand CEO Adam Steensberg, M.D., said in a statement. “We believe the outcome of this trial supports the potential of dasiglucagon as a novel treatment for those living with CHI. We look forward to engaging with the U.S. FDA and moving forward with our new drug application.”

Zealand is working with Deka Research & Development on the continuous infusion pump. The pump has already been cleared for use by the FDA in other contexts and, as Zealand sees things, can reduce or eliminate the need for intensive hospital treatment when used to deliver dasiglucagon.