Clinical Trials

* On March 2, 2016, Zealand Pharma announced top-line results from its clinical Phase II Proof-of-Concept trial with danegaptide for the protection against cardiac reperfusion injuries in patients with an acute myocardial infarction. Results show no effect of danegaptide on the primary endpoint of saving cardiac tissue from ischemic reperfusion injuries as measured on the Myocardial Salvage Index (MSI). Danegaptide has demonstrated cell protective and anti-arrhythmic properties and shown significant effect in established preclinical models of cardiac ischemic reperfusion injuries. Despite substantial improvements in the treatment of patients with ST-elevation myocardial infarction (STEMI), danegaptide didn't demonstrate a therapeutic benefit to patients.  Results from the trial showed no effect for danegaptide compared to placebo on the primary endpoint of MSI as a measure for cardiac tissue salvage, when added to the standard therapy provided. Data from secondary efficacy endpoints were consistent with the results on the primary endpoint. In the trial, danegaptide demonstrated to be safe and well tolerated.
Zealand will evaluate the complete data set and discuss with key medical experts to review all aspects of the trial outcome.

* On October 29, 2014, Zealand Pharma announced that the company presented a case study on danegaptide as a novel and innovative peptide therapeutic and potential first-in-class gap junction modifier at the 9th Annual Peptide Therapeutics Symposium, which recently took place in La Jolla, California, the U.S. In the presentation, entitled “Danegaptide - Potential First and Best in Class Peptide Medicine for Prevention of Myocardial Reperfusion Injury”, Rie Schultz Hansen, Principal Scientist at Zealand, outlined that danegaptide has both anti-arrhythmic and cell-protective properties, and that this novel peptide has been shown to protect cardiac tissue in preclinical models of ischemic reperfusion injuries, causing significant reductions in infarct sizes in both dogs and pigs. Further, she presented the design and status of the ongoing clinical Phase II Proof-of-concept trial on danegaptide, conducted by Zealand in collaboration with Rigshospitalet in Denmark, one of Europe’s leading cardiac centres with key expertise in Acute Myocardial Infarction (AMI). To date, more than 50% of the targeted 600 patients with an AMI have been enrolled and treated, and the study is on track to complete and report results in H2 2015.

In collaboration with the Copenhagen University, Zealand also has a project ongoing to investigate the full therapeutic potential of danegaptide as a novel approach in the protection of tissue from ischemic reperfusion injuries. The project was selected by the Danish Innovation Fund (InnovationsFonden) to receive a DKK 1 million grant.

* On November 20, 2013, Zealand Pharma has announced that the first patient has been treated in a Phase II Clinical Proof-of-Concept study of danegaptide. The objective of this Phase II study is to assess the efficacy and safety of danegaptide in reducing tissue damage from reperfusion injuries in patients with an acute myocardial infarction (ST-segment elevation myocardial infarction, STEMI) when added to standard treatment in the form of balloon dilatation (primary PCI). Danegaptide has shown promising therapeutic properties in several relevant preclinical MI models assessing cardiac reperfusion injury. In a Phase I program, including 153 healthy subjects in three studies, danegaptide has been shown to be safe and well tolerated. The danegaptide Phase II Clinical Proof-of-Concept study is expected to complete in the 2nd half of 2015.