A Danish biotechnology company, Zealand Pharma announced its candidate for severe hypoglycemia achieved primary and key secondary endpoints in pivotal Phase 3 trial, making it one step closer to potential regulatory approval.
The trial assessed the efficacy of dasiglucagon, for the treatment of insulin-induced hypoglycemia in Type 1 diabetes patients.
Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma. It is in development in the ready-to-use HypoPal® rescue pen for easy, fast and effective treatment of severe hypoglycemia, according to a company statement.
According to results, 99 percent of subjects recovered from insulin-induced hypoglycemia (low levels of blood sugar) within 15 minutes following dosing with dasiglucagon.
That was compared to 2 percent of patients who took a placebo and 95 percent of patients who used Novo Nordisk’s GlucaGen.
Trial results showed that the median time to blood glucose recovery was 10 min for dasiglucagon. Patients who used the Novo Nordisk recovery medication had a median recovery time of 12 minutes and placebo patients had a median recovery time of 40 minutes.
Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively).
“The compelling Phase 3 results bring the dasiglucagon HypoPal® rescue pen a significant step closer to a better treatment for people living with diabetes, addressing one of their biggest fears,” said Britt Meelby, president and chief executive officer at Zealand Pharma.
“I am thrilled about this achievement, which represents an important milestone for Zealand in executing our strategy of bringing fully-owned products through registration,” she added.
Severe hypoglycemia occurs most frequently in people with Type 1 diabetes due to injecting insulin multiple times daily. It is a significant concern for diabetics and is characterized by confusion and seizures.
Patients can lose consciousness and if it is left untreated, severe hypoglycemia can lead to death. Dasiglucagon is being developed to offer a stable ready-to-use rescue treatment for severe hypoglycemia.
Zealand Pharma plans to initiate a Phase 3 trial in pediatric diabetes patients, which is expected to complete in mid-2019.
Dasiglucagon is also in development for two additional indications: The treatment of Type 1 diabetes with a next-generation artificial pancreas, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).