Zealand Initiates Second Late-Stage CHI Study On Dasiglucagon
Zacks Investment Research | Dec 04, 2019 09:07PM ET
Zealand Pharma A/S (NASDAQ:ZEAL) announced that it has initiated the second phase III study to evaluate its pipeline candidate, dasiglucagon, in pediatric patients with congenital hyperinsulinism (“CHI”).
The CHI disease is a rare pediatric disease, primarily affecting newborns, infants and toddlers, which can lead to debilitating lifelong complications like high insulin levels. Treatment options currently available are often insufficient and necessitate surgical intervention through pancreatectomy.
Shares of Zealand were up 7.1% on Dec 4 following the announcement. The company’s shares have surged 181.7% so far this year compared with the industry ’s increase of 5.3%.
The new phase III study is designed to evaluate dasiglucagon in 12 CHI patients who are aged between 7 days to 1 year and are dependent upon intravenous glucose infusions to maintain their plasma glucose levels. The efficacy of the candidate will be measured on the basis of reduction in the intravenous glucose infusion rate, number of hypoglycemic events, and total amount of carbohydrate administered.
An ongoing phase III study is evaluating dasiglucagon versus current standard treatments for reducing the number of hypoglycemic events in CHI patients aged 3 months to 12 years. Results from this study are expected next year.
We note that dasiglucagon enjoys orphan drug designation both in the United States and Europe for treating CHI patients. The FDA also granted a rare pediatric disease designation in 2019 for this indication.
Apart from CHI, Zealand is also developing dasiglucagon across several indications including severe hypoglycemia and diabetes management.
In September, the company announced positive results from the pediatric phase III study evaluating dasiglucagon for severe hypoglycemia in diabetes. Dasiglucagon is a potential first-in-class soluble glucagon analog, which is being developed in the ready-to-use HypoPal rescue pen. Data from the study demonstrated that patients treated with the candidate improved the time to increase in plasma glucose of greater than equal to 20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.
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