Zealand Pharma reports completion of the first Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia

Press release - No. 5/2018

Zealand Pharma reports completion of the first Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia

• Last patient visit concluded in the multinational Phase 3 trial, with key results expected
  mid-Q2 2018
• Dasiglucagon is a potential first-in-class stable glucagon analog to be launched in the HypoPal^® rescue pen for the treatment of severe hypoglycemia
• Results from a second Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia are expected in late 2018

Copenhagen, February 21, 2018 - Zealand Pharma A/S ("Zealand") announces that the multinational Phase 3 clinical trial of dasiglucagon in four countries (Austria, Germany, Canada and the U.S.) has been completed, with the last patient visit concluded.

Dasiglucagon is a potential first-in-class stable glucagon analog invented and developed by Zealand. It has a unique stability profile in liquid formulation and is suitable for a ready-to-use rescue pen to treat severe hypoglycemia. Phase 2 clinical results indicate that dasiglucagon rapidly increases plasma glucose levels after insulin-induced hypoglycemia, with a longer-lasting and more pronounced plasma glucose increase with dasiglucagon compared to the active comparator, GlucaGen.¹The HypoPal^® rescue pen development program has an attractive risk profile as it is based on a proven concept.

The aim of this first Phase 3 trial was to evaluate the immunogenicity of repeated single doses of dasiglucagon (0.6 mg) following subcutaneous administration in patients with type 1 diabetes, as well as effect, safety and tolerability. Dasiglucagon was compared to glucagon powder (GlucaGen^®) that requires reconstitution immediately before injection via a syringe. The trial was conducted over 15 weeks, during which 90 patients were exposed to either dasiglucagon or GlucaGen^® in a parallel, randomized, double-blind design.

Adam Steensberg, Executive Vice President, Chief Medical and Development Officer of Zealand, comments: "We are very happy with the advancement of the clinical development of our dasiglucagon HypoPal^® rescue pen for the treatment of severe hypoglycemia in diabetes. In addition to completing this first Phase 3 trial, we are on track with patient recruitment in a confirmatory Phase 3 trial initiated in late 2017. We aim to ultimately provide patients and their relatives with an easy-to-use solution to treat severe hypoglycemic events, which can be life-threatening and are one of the biggest concerns for people on insulin treatment."

The results from the trial are expected by mid-Q2 2018. In addition to this trial, a confirmatory Phase 3 trial was initiated late 2017, and patient recruitment is progressing as planned, with results expected in late 2018.

Diabetes and severe hypoglycemia
People with type 1 diabetes suffer from insulin deficiency and inappropriate glucagon secretion - both hormones are essential to ensure stable and healthy blood glucose levels. Consequently, patients must monitor and adjust their blood glucose levels to remain in proper glycemic control, as both high and low blood glucose may affect their health, both in the short and long term.
Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is still the biggest concern for insulin-dependent patients and the most feared complication of diabetes treatment. Severe hypoglycemia is most frequently seen in people with type 1 diabetes and type 2 diabetes patients on insulin, since they inject themselves with insulin multiple times a day. These events are characterized by confusion, seizures and, often, loss of consciousness, which, if left untreated, can result in death.
Currently marketed formulations of glucagon for the treatment of severe hypoglycemia need to be mixed and used immediately due to their limited stability in solution. Dasiglucagon is being developed to offer a ready-to-use treatment for severe hypoglycemia in the HypoPal^® rescue pen.

About dasiglucagon
Dasiglucagon is a Zealand-invented proprietary glucagon analog currently in development for three different indications: in a dual-hormone artificial pancreas for diabetes treatment, as a rescue treatment for severe hypoglycemia and to treat congenital hyperinsulinism.

For further information, please contact:
Britt Meelby Jensen, President and CEO
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com
Mats Blom, Executive Vice President and Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of proprietary medicines in late-stage clinical development focused on specialty gastrointestinal and metabolic diseases. In addition, Zealand has two marketed drugs under license to Sanofi and two compounds in clinical development under license to Boehringer Ingelheim.
Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.

1 https://doi.org/10.2337/dc17-1402

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