Zealand Pharma (NASDAQ:ZEAL) is up 4% premarket on light volume in reaction to its announcement of positive results from a confirmatory Phase 3 clinical trial evaluating dasiglucagon for the treatment of severe hypoglycemia (low blood sugar) in diabetes.
The results showed that a single dose of dasiglucagon administered via the HypoPal rescue pen rapidly increased blood glucose levels in adults with type 1 diabetes following insulin-induced hypoglycemia. Specifically, the median time to blood glucose recovery was 10 minutes for dasiglucagon compared to 35 minutes for placebo (p<0.001).
On the safety front, the most frequent treatment-related adverse events were nausea (62%) and vomiting (29%).
A final Phase 3, in pediatric diabetes patients, is in process with topline data expected in September.
The company plans to file a U.S. marketing application in early 2020.
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