Dive Brief:
- Zealand Pharma A/S's glucagon analog, dasiglucagon, met its primary and secondary endpoints in its first multinational Phase 3 study for the treatment of severe hypoglycemia.
- The study, designed to assess immunogenicity of repeated single doses, showed no treatment-induced or treatment-boosted anti-drug antibodies detected. Copenhagen-based Zealand is developing the product for use in a ready-to-use rescue pen.
- Further results from this study will be released during the second quarter of 2018, followed by data from the pivotal Phase 3 trial in the second half of the year. Shares on NASDAQ closed up 10%.
Dive Insight:
Insulin-dependent diabetics, both type 1 and type 2, can have episodes of severe hypoglycemia, resulting in confusion, loss of consciousness and even death.
With six million or more people across the U.S. using insulin, there's a major need for a treatment for hypoglycemia.
While mild hypoglycemia can be treated by eating or drinking something high in carbohydrates, severe acute episodes require intravenous glucose or an injection of glucagon. Glucagon powder, such as in the GlucaGen HypoKit, requires reconstitution and injection with a syringe. Zealand's approach is a ready-to-use "rescue pen" known as HypoPal.
"The positive results from the Phase 3 trial is a major step forward in the development of the HypoPal rescue pen for the treatment of severe hypoglycemia. This remains one of the biggest fears among insulin-dependent diabetics leading to approximately 300,000 hospitalizations per year in the U.S. alone," said Adam Steensberg, chief medical officer of Zealand.
In Phase 2 clinical trials, dasiglucagon rapidly increased plasma glucose levels after insulin-induced hypoglycemia, with a longer-lasting and more pronounced plasma glucose increase compared with an active comparator.
Dasiglucagon is also in development in congenital hyperinsulinism, an ultra-rare disease where insulin secretion is elevated, leading to frequent, severe and damaging hypoglycemia. Phase 3 trials are planned for the second half of 2018. Zealand is also carrying out Phase 2 trials for a dual-hormone artificial pancreas for diabetes treatment. Positive Phase 2a results showed that the combination of dasiglucagon and insulin in the iLet dual-hormone artificial pancreas system were effective at controlling blood sugar. A longer Phase 2b trial is planned for 2018.