Zealand announces results of a Phase II Proof-of-Concept trial with danegaptide for cardiac reperfusion injuries

• Danegaptide did not meet the primary efficacy endpoint of reducing ischemic reperfusion injuries, measured on the Myocardial Salvage Index, in patients with an ST-elevation myocardial infarction undergoing the standard treatment of PCI

• In the trial, danegaptide was shown to be safe and well tolerated

COPENHAGEN, Denmark, March 2, 2016 -- Zealand announces 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 (blood clot in the heart). 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 is a Zealand invented peptide and the first in a new class of gap junction modifiers. The compound 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), significant unmet medical needs remain in the field, primarily associated with reperfusion injuries.

Britt Meelby Jensen, President and CEO of Zealand , said: "We had obviously hoped with this study to demonstrate a therapeutic benefit of danegaptide to patients. Cardiac damage remains a serious challenge following a heart attack, so in this sense, we are disappointed. Based also on the strong results seen with danegaptide in preclinical studies, we still think this was a relevant opportunity for us to explore despite the fact that this is a notoriously difficult therapeutic area, where many other drug candidates have failed. On behalf of Zealand, I would like to thank all patients and the study investigators at Rigshospitalet's Cardiac Center for their participation in this very well-conducted trial.

And she continued : "Internally, we will focus our resources on the many activities ongoing in our growing proprietary pipeline. This includes the two clinical Phase II programs, which we have initiated this year with our two investigational specialist medicines, ZP1848 for Short Bowel Syndrome and ZP4207 for hypoglycemia in diabetes, respectively."