Zealand Pharma's Dasiglucagon Phase IIa Results at the 11th International Conference on ATTD

Zealand Pharma A/S' dasiglucagon Phase 2a results will be presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes

  • Dasiglucagon was dosed using the automated dual-hormone artificial pancreas algorithm in development for the leading dual-hormone pump, iLetTM.
  • Dasiglucagon, a novel glucagon analog suitable for pump use, was effective in controlling blood glucose when used together with insulin in patients with type 1 diabetes.

Copenhagen, February 15, 2018 - Dr. Steven J. Russell, Massachusetts General Hospital, Boston, U.S., principal investigator for Zealand Pharma's ("Zealand") Phase 2a trial of dasiglucagon in patients with type 1 diabetes, will present key data from the trial at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Vienna, Austria, on February 14-17, 2018.

Dual-hormone artificial pancreas pumps with fully automated dosing of insulin and glucagon have the potential to provide a paradigm shift in the treatment of patients with type 1 diabetes. Dasiglucagon is stable in aqueous formulation and is a potential first-in-class glucagon analog suitable for pump use. Together with its device partner, Zealand hopes to provide patients with a more effective, safer and easier option for the automated management of diabetes.

The aim of the trial was to demonstrate the effectiveness, safety and tolerability of dasiglucagon compared to glucagon for reconstitution in a dual-hormone artificial pancreas system in 12 adults with type 1 diabetes. Dasiglucagon was observed to be safe and well tolerated in the trial. There were no significant differences in the percentage of time that participants spent in different glycemic targets between dasiglucagon and the glucagon for reconstitution. The trial provides the basis for bridging early clinical data from older glucagon products that need to be reconstituted immediately before use to future clinical trials with dasiglucagon in a prefilled ready-to-use cartridge in dual-hormone artificial pancreas pumps.

Steven J. Russell, MD, Massachusetts General Hospital Diabetes Center, Boston, U.S., comments: "This is an important step in demonstrating the feasibility of using dasiglucagon with the same dosing algorithms that have been developed at Beta Bionics and integrated into the iLet(TM) bionic pancreas. We tested the dual-hormone artificial pancreas' performance while delivering dasiglucagon in the face of real-life challenges such as skipping meals, exercising and overdosing insulin during an eight-hour period and found that dasiglucagon performed comparably to recombinant reconstituted glucagon. A stable, pumpable glucagon is critical to the practical use of the bihormonal bionic pancreas, so I am looking forward to participating in longer-duration outpatient studies with dasiglucagon in iLet(TM)."

Adam Steensberg, Executive Vice President, Chief Medical and Development Officer of Zealand, comments: "We are pleased with the Phase 2a results which, for the first time, demonstrate that dasiglucagon is effective in a dual-hormone artificial pancreas pump setting. Management of blood glucose is a constant struggle for patients with type 1 diabetes. With the current results, we are one step closer to a future with fully automated diabetes care fueled by dasiglucagon in dual-hormone pumps."

About type 1 diabetes and dual-hormone artificial pancreas systems
People with type 1 diabetes suffer from insulin deficiency and, often, inappropriate glucagon secretion. Both hormones are essential to ensure healthy blood glucose levels. Treating type 1 diabetes while utilizing both hormones would potentially mimic physiological regulation. The dual-hormone artificial pancreas system could limit the complexity of such treatment. It would be more accessible for a significant proportion of people with type 1 diabetes, who would otherwise not be able to handle multiple finger prick tests and adjustments of insulin and glucagon doses to maintain glycemic control. In a recent review, dual-hormone artificial pancreas systems were associated with a greater improvement in time in target range and a simultaneous reduction in hypoglycemia compared to single-hormone systems (Weisman, Alanna, et al, The Lancet Diabetes & Endocrinology, Volume 5, Issue 7, 501-512).

About dasiglucagon
Dasiglucagon is a Zealand-invented proprietary glucagon analog currently in development for three different indications: 

  • Dual-hormone artificial pancreas for diabetes treatment
    Zealand has already reported positive results from two Phase 2a trials during the second quarter of 2017 (Zealand Pharma company releases of 23-05-2017 and 22-06-2017), and the initiation of an outpatient Phase 2b trial of longer duration is planned for 2018 in the iLetTM dual-hormone artificial pancreas system. 
  • Rescue treatment for severe hypoglycemia
    Ready-to-use dasiglucagon may offer diabetes patients and their families a fast treatment solution for severe hypoglycemia that is easier to use than currently marketed glucagon kits. The first Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia was initiated in July 2017, with recruitment completed in October 2017. Results are expected in Q2 2018, ahead of previous expectations. A second Phase 3 trial was initiated in December 2017, with results expected in H2 2018. 
  • Congenital hyperinsulinism
    Congenital hyperinsulinism (CHI) is an ultra-rare but devastating disease caused by inappropriately elevated insulin secretion irrespective of glucose levels. This leads to frequent and often severe hypoglycemia and long-term irreversible damage to health. In 2017, the FDA in the U.S. and the Committee for Orphan Medicinal Products (COMP) in the EU issued a positive opinion on an orphan medicinal product application for Zealand's glucagon analog. In January 2018, the FDA issued a safe-to-proceed letter, and the Phase 3 program is expected to start in mid-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 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.

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