Policy & Regulation
Zealand Pharma reports achievement of primary and all key secondary endpoints in confirmatory phase 3 trial with dasiglucagon for severe hypoglycaemia
15 May 2019 -

Zealand Pharma A/S (Zealand) (Nasdaq: ZEAL), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced on Tuesday successful results in the confirmatory phase 3 trial with dasiglucagon for severe hypoglycaemia in diabetes.

Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal rescue pen, an auto-injector for easy, fast and effective treatment of severe hypoglycaemia in people with diabetes.

This phase 3 trial confirms that a single dose of dasiglucagon administered via the HypoPal rescue pen rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycaemia. The company said that 45 subjects were included in the trial, which compared the glycaemic response observed after dosing of dasiglucagon with that of placebo. The primary endpoint was time to plasma glucose recovery.

Overall, no safety concerns were raised for dasiglucagon within the trial.

According to the company, this is the third consecutive phase 3 trial with positive results for dasiglucagon. The previous immunogenicity and pivotal phase 3 trials established dasiglucagon's safety profile and fast onset of action when administered via a pre-filled syringe in adult patients with type 1 diabetes.

The final phase 3 trial that will complete Zealand's NDA application is in paediatric diabetes patients and is still ongoing. Recruitment for this study involving children has proved challenging and results are now expected in September 2019. Accounting for this delay in paediatric patient recruitment, submission of the new drug application (NDA) to the U.S. FDA is now expected early 2020.

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