Primary Objective Met in Phase 3 of Hypoglycemia Treatment

It was announced this morning that dasiglucagon has met its primary and key secondary objectives in its multinational Phase 3 clinical trial in patients with severe hypoglycemia.

Dasiglucagon is a potential first-in-class stable glucagon analog to be launched in the HypoPal rescue pen. No treatment-induced or treatment-boosted anti-drug antibodies were detected in the trial.

The primary and key secondary objectives in the trial were to gauge the risk of treatment-induced and treatment-boosted anti-drug antibodies after 3 repeat doses of dasiglucagon, which Zealand Pharma A/S will market as GlucaGen.

Dasiglucagon has a distinctive safety profile and a unique stability profile in liquid formulation and is fit for patients with the acute, life-threatening condition to receive via a ready-to-use rescue pen.

The condition is the result of a severe drop in blood glucose levels, and is primarily associated with insulin therapy. It is often found in people with type 1 diabetes or type 2 diabetes patients on insulin. Current standard of care mostly includes dietary control and glucose monitoring, but a pharmacokinetic and pharmacodynamics evaluation of dasiglucagon proved its ability to quickly increase plasma glucose levels after insulin-induced hypoglycemia, with a longer-lasting and more pronounced plasma glucose increase than has previously been seen.

"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,” said Adam Steensberg, Executive Vice President, Chief Medical and Development Officer of Zealand in a press release. “This remains one of the biggest fears among insulin-dependent diabetics leading to approximately 300,000 hospitalizations per year in the U.S. alone. We now look forward to completing the ongoing pivotal Phase 3 efficacy trial later this year and we remain fully committed to offering this easy-to-use solution to treat a life-threatening condition."

The Phase 3 trial was designed to evaluate the immunogenicity of repeated single doses of dasiglucagon at a 0.6 mg dose following subcutaneous administration in 90 patients with type 1 diabetes, but also evaluated safety and tolerability. The drug was compared to native glucagon powder that requires immediate reconstitution in an aqueous buffer before injection with a syringe.

In addition to this trial, a pivotal Phase 3 efficacy trial was initiated in December 2017, and patient recruitment is ongoing. Results are expected in the second half of 2018.

Zealand expects to publish additional results from the trial in the second quarter of 2018 and present them at a future scientific conference.

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