10 minutes quick reversal! Zealand Innovative Therapy Treats Children's Hypoglycemia Phase III Clinical Success!

Zealand Pharma is a Copenhagen, Denmark-based biotechnology company dedicated to the discovery and development of innovative peptide-based therapiesRecently, the company announced the positive results of a clinical study in pediatrics phase III to evaluate dasiglucagon's treatment of severe hypoglycemiaDasiglucagon, a potentially first-of-all soluble glucagon analogue, is currently being developed for ready-to-use HypoPal first aid pen, an auto-injector for simple, rapid and effective treatment of severe hypoglycemia in diabeticsthe study, a randomized, double-blind, placebo, and positive drug control, parallel group study conducted in children with type 1 diabetes treated with insulin, investigated the efficacy, safety, and pharmacokinetics of dasiglucagon as a reseondotic treatment for severe hypoglycemia compared to placebo and GlucaGenGlucaGen is a now-marketed glucagon powder that needs to be formulated before injectionThe blood glucose response given dasiglucagon (0.6 mg), placebo, glucaGen (1 mg) treatment after inducing hypoglycemia was observed in the studyThe primary endpoint is the recovery time of blood sugar, defined as the first increase in blood sugar from baseline levels of 20 mg/dL (1.1 mmol/L) without giving resuscitation glucoseA total of 42 child subjects (divided into 6-11 years and 12-17 age groups) were enrolled in the study, 21 were assigned to the dasiglucagon treatment group, 11 were assigned to the placebo group and 10 were assigned to the GlucaGen treatment groupresults showed that the median recovery time of blood sugar in the dasiglucagon treatment group was 10 minutes, better than that of the placebo group (median 30 minutes, p 0.001)The median recovery time in the GlucaGen treatment group was 10 minutesThe results also support the use of the same dose of dasiglucagon in adults and childrenThe Adult Phase III study, published in May, showed that dasiglucagon was able to quickly restore blood sugar within 10 minutes of administration, better than placebo (median time of blood sugar recovery: 35 minutes, p0.001)Dasiglucagon did not raise security issuesNausea and vomiting were reported in both age groups treated by Dasiglucagon, 25 per cent of nausea and 25 per cent in the 6-11 age group, 92 per cent in the 12-17 age group and 67 per cent in the vomiting age groupIn the GlucaGen treatment group, the incidence of nausea was 50% in the 6-11 age group, 25% in the vomiting age group, 17% in the 12-17 age group and 0% in the vomiting age groupthis study is another Phase III study that has tested positive results for the dasiglucagon HypoPal first aid pen program, confirming the potential of dasiglucagon to quickly and effectively save severe hypoglycemia in children with diabetesThe study is also the fourth consecutive Phase III study to assess positive results for dasiglucagon for treatment of severe hypoglycemia Previous Phase III studies of immunoogenics and Criticality identified the safety and rapid effectiveness of treating severe hypoglycemia in adult patients with type 1 diabetes by dasiglucagon through PalHypo first aid pens and pre-filled syringes based on the project's data, Zealand plans to submit a new drug application to the FDA in early 2020 in addition to developing severe hypoglycemia for patients with type 1 diabetes, Zealand is also developing two additional indications for dasiglucagon for the treatment: Patients with type 1 diabetes using the next generation of artificial pancreas; genetic mutations lead to congenital hyperinsulinemia in children reference source: Zealand Pharma primary and all key primary endpoints in pediatric Phase 3 trial with dasiglucagon for the severe hypoglycemia