Clinical Zealand Pharma Presents Clinical Results From the Phase 3...

Zealand Pharma Presents Clinical Results From the Phase 3 Trial of Dasiglucagon

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Zealand Pharma A/S has revealed that it recently shared the clinical findings from the Phase 3 trial of dasiglucagon at the recently held 60th annual European Society for Pediatric Endocrinology (ESPE) conference.

The Phase 3 trial – conducted in two parts – aims to treat newborn babies and infants who suffer from congenital hyperinsulinism (CHI). The trial was conceived to understand whether chronic dasiglucagon infusion could help prevent hypoglycemia in children recently diagnosed with CHI, causing them to be dependent on intravenous glucose.

Congenital hyperinsulinism (CHI) is an uncommon genetic illness impacting newborns, infants and children. CHI causes the insulin cells of the pancreas – known as beta cells – to secrete excessive insulin irrespective of the glucose levels. This causes acute and constant hypoglycemia throughout childhood.

Dasiglucagon – created by Zealand Pharma and sold under the name Zegalogue – is a medication used to treat severe hypoglycemia. The FDA and European Comission granted it orphan drug status in 2017.

Part 1 of the trial consisted of two placebo-controlled periods of 48 hours each, while Part 2 was a single-arm, open-label investigation of the dasiglucagon administration for an additional 21 days. 

In Part 1, dasiglucagon had a big impact on the requirement for intravenous (IV) glucose to maintain glycemia in infants with CHI; a significant reduction was observed. It also shot down the glucose requirements to a level that would allow the discontinuation of the IV glucose support altogether.

In the last 12 hours of the treatment period, dasiglucagon lowered the mean glucose infusion rate (GIR) by over 50% compared to placebo. The rate was found to be 4.3 mg/kg/min for dasiglucagon and just under 9.5 mg/kg/min for placebo., The difference of 5.1 mg/kg/min is quite notable. Taking into account the entire 48-hour treatment period, dasiglucagon reduced the GIR by 3.5 mg/kg/min.

Overall, dasiglucagon proved to be quite well-tolerated in the first part. Gastrointestinal issues and skin reactions were reported as the most frequently occurring adverse events during the period, although there was no major danger for anyone involved.

The second part of the Phase 3 trial also yielded positive results. In over 80% of the participating infants, dasiglucagon caused temporary or permanent depletion of IV glucose infusion. Furthermore, as many as seven infants who didn’t require pancreatectomy were entirely taken off IV glucose at the end of the trial. The safety profile of dasiglucagon was consistent with the first part – there was no complication that needed the treatment to be discontinued.
Diva D. De León-Crutchlow, the chief investigator of the study, said, “Children with CHI can experience significant and permanent neurologic complications as a result of hypoglycemia, and many infants are dependent on intravenous glucose, and in some cases require pancreatectomy, to maintain euglycemia. I am encouraged by the results from Part 1 of this Phase 3 study demonstrating that dasiglucagon treatment resulted in a significant reduction in glucose infusion rate, and to see this trend continue in Part 2.”

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