Company announcement - No. 55/2017
Zealand Pharma initiates the pivotal Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia in
diabetes
- First patient recruited in the second Phase 3 clinical trial of dasiglucagon
- Dasiglucagon is a potential first-in-class soluble glucagon analog, for delivery in a ready-to-use rescue pen to treat
severe hypoglycemia
- Results from the Phase 3 trial expected in H2 2018
Copenhagen, December 7, 2017 - Zealand Pharma A/S ("Zealand") announces the initiation of the second Phase 3 trial to
confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of severe hypoglycemia in patients with Type 1
Diabetes (T1DM).
Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma. It has a unique
stability profile in liquid formulation with no preservatives and is suitable for a ready-to-use rescue pen to treat severe
hypoglycemia. The Phase 2 clinical results, which were presented at the American Diabetes Association meeting in June 2017,
indicated that:
- dasiglucagon rapidly increases plasma glucose (PG) levels after insulin-induced hypoglycemia, with a longer lasting and more
pronounced PG increase when compared to reconstituted glucagon.
- there were fewer post dosing hypoglycemia events with dasiglucagon (two events within six hours) compared to
reconstituted glucagon (nine events within six hours).
The first Phase 3 trial was initiated in July 2017. Recruitment was completed in October 2017 and results are expected in Q2
2018, ahead of previous expectations.
The aim of this pivotal Phase 3 trial is to confirm rapid PG increase after single dose administration of
dasiglucagon to subjects with type 1 diabetes mellitus with insulin-induced hypoglycemia. The secondary aim is to
compare the glycemic response observed after administration of dasiglucagon with that of reconstituted glucagon currently marketed
in powder form. The trial will be conducted in 156 patients, exposed to either dasiglucagon, placebo or reconstituted glucagon in a
parallel randomized double-blind design.
Britt Meelby Jensen, President and CEO of Zealand, comments: "The initiation of this second Phase 3 trial brings us
closer to making our dasiglucagon rescue pen available to patients. Many people with diabetes and their relatives live with the
constant fear of experiencing too low blood sugar levels. A user-friendly solution to address severe hypoglycemia, or insulin
shock, holds potential to significantly reduce this fear and to better patient care."
Type 1 Diabetes and 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. Severe hypoglycemia is most frequently seen in people with Type 1 Diabetes due to injecting insulin
multiple times daily. Severe hypoglycemic events occur when blood glucose levels become critically low and it is the biggest
concern for insulin-dependent patients and the most feared complication of diabetes treatment. It is a condition characterized by
confusion, seizures and, often, loss of consciousness which, if left untreated, can result in death. The patient requires
assistance from another person to treat.
Currently marketed formulations of glucagon for the treatment of severe hypoglycemia require mixing first by the person
assisting to treat and then immediate administration due to poor drug stability. Dasiglucagon is being developed to offer a stable
ready-to-use rescue treatment for severe hypoglycemia.
Dasiglucagon (glucagon analog stable in liquid formulation) for use in other indications
Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution also in
development for two additional indications.
Treatment of Type 1 Diabetes with a next-generation artificial pancreas pump containing both insulin and glucagon (dasiglucagon)
with potential to bring a paradigm shift in treatment, improving blood glucose control, with limited patient intervention. Zealand
reported positive results from two Phase 2a trials in Q2 2017 for this treatment option and a Phase 2b trial is planned for
2018.
Dasiglucagon also holds potential to treat the rare pediatric disease congenital hyperinsulinism. This severe condition covers
several congenital disorders caused by gene mutations in the pancreatic beta-cells resulting in too high circulating insulin levels
and associated severe and persistent low blood glucose levels and. In June 2017, the European Commission granted orphan medicinal
product designation for dasiglucagon. This was followed by the granting of a similar orphan drug designation by the U.S. FDA in
August 2017. A Phase 2 clinical trial is expected to start during H1 2018.
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, 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 medicines and product candidates under license
collaborations with Sanofi, Boehringer Ingelheim and a pipeline of internal product candidates focusing on specialty
gastrointestinal and metabolic diseases.
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 Linked-in or Twitter @ZealandPharma.
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