×

Results from a multiple-dose Phase Ib trial support the potential of Zealand's stable glucagon analogue, ZP4207, for the correction of mild to moderate hypoglycemia

  • Data demonstrate that ZP4207 was safe and well-tolerated with the ability to provide a clinically relevant blood glucose response after repeat daily dosing in healthy volunteers
  • The results provide further support for the use of ZP4207 as a multiple-dose version, including potential as a component in an artificial pancreas device, to correct low blood sugar levels in patients with Type 1 diabetes
  • Ongoing preparations for the next step clinical development of ZP4207 as a single-dose rescue-pen for severe hypoglycemia are progressing according to plan

COPENHAGEN, Denmark, Sept. 9, 2015 (GLOBE NEWSWIRE) -- Zealand announces that results from a clinical Phase Ib trial with its novel glucagon analogue, ZP4207 show good safety and tolerability after multiple dosing. In addition, it was shown that ZP4207 leads to clinically relevant increases in blood glucose levels.

ZP4207, which was invented and is wholly-owned by Zealand, has shown a good stability profile in liquid formulation, supporting its potential as a product immediately ready for use.

The randomized, double-blind and placebo-controlled Phase Ib trial was conducted by Zealand at a clinical diabetes center in Germany and enrolled 24 healthy volunteers. The trial objectives were primarily to evaluate safety and tolerability and secondarily to assess pharmacokinetics and pharmacodynamics of ZP4207 after multiple dosing. Participants in the trial received three different doses of ZP4207, each over 5 consecutive days. The trial was funded under a USD 1.8 million grant from the Helmsley Charitable Trust to support preclinical and initial clinical activities related to the multiple-dose version of ZP4207.

Commenting on the positive outcome of the Phase Ib trial, Britt Meelby Jensen, President and CEO of Zealand, said: "We are encouraged by the results obtained for our stable glucagon analogue, ZP4207 after repeated dosing. We are currently advancing preparations to take a single-dose version of the product forward in clinical development as a ready-to-use rescue pen for the treatment of severe hypoglycemia. These latest results support also the further potential of ZP4207 in a multiple-dose version to correct mild to moderate hypoglycemia - e.g. as a mini-dose pen or in a dual-hormone artificial pancreas device. We believe ZP4207 could be an important advance in the treatment of patients with Type 1 diabetes, and the product is an important part of our growing proprietary pipeline of novel medicines. We look forward to sharing further news as we progress its development."

Results from a Phase I trial with a single-dose version of ZP4207 were announced in June this year, showing good safety and tolerability after single-dosing in both healthy volunteers and Type 1 diabetes patients. Further, effects were shown in raising blood glucose levels in Type 1 diabetes patients after an insulin-induced hypoglycemic event.

Zealand is progressing preparations towards a next clinical trial with ZP4207 as a single-dose ready-to-use rescue pen to treat severe hypoglycemia events. Based on the results from the repeat dosing Phase Ib trial, Zealand will evaluate additional options for further development of a multiple-dose version of ZP4207.

?????

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer

Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President for Investor Relations and Communications

Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company with leading expertise in the identification, design and development of novel peptide medicines. Zealand has a proprietary pipeline of novel drug candidates and a portfolio of products and projects under license collaborations with Sanofi, Helsinn Healthcare and Boehringer Ingelheim - primarily in the fields of cardio-metabolic diseases and acute care indications.

The proprietary pipeline includes danegaptide for ischemic reperfusion Injuries in Phase II development and the stable glucagon analogue, ZP4207 in two clinical development programs; as a single-dose rescue pen for severe hypoglycemia and as a multiple-dose version for the correction of mild to moderate hypoglycemia, in preparation and evaluation, respectively for next clinical phase after Phase I trials, as well as several preclinical peptide therapeutics.

Zealand has invented lixisenatide, a once-daily prandial GLP-1 agonist, which is marketed globally (ex-US) by Sanofi for the treatment of Type 2 diabetes. Sanofi submitted lixisenatide for regulatory approval in the US in late July 2015, and has a combination of lixisenatide with insulin glargine (Lantus(r)) in Phase III development with regulatory submissions expected in Q4 2015 in the US and in Q1 2016 in Europe.

The company is based in Copenhagen (Glostrup), Denmark. For further information about Zealand's business and activities, please visit: www.zealandpharma.com

Source: Zealand Pharma A/S