Zealand Begins Danegaptide POC Trial

Zealand Pharma A/S has begun treating the first patient in a Phase II proof-of-concept study of danegaptide. Danegaptide is a novel dipeptide with potential as a first-in-class medicinal treatment to reduce tissue damage caused by reperfusion.

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, or STEMI) when added to standard treatment in the form of balloon dilatation (primary PCI). The study is a randomized, double-blind, placebo-controlled study, which will be conducted at Rigshospitalet in Copenhagen. It is expected to enroll a minimum of 600 STEMI patients, who will be randomized to treatment with either a high or a low dose of danegaptide or placebo in connection with a PCI procedure.

The primary study endpoint is assessing the therapeutic effect of danegaptide in the reduction of tissue damage, measured as myocardial salvage index three months after the PCI procedure, by use of magnetic resonance imaging. The myocardial salvage index is a documented, strong prognostic marker for cardiac outcome (e.g. death and heart failure). Secondary study endpoints include clinical events of heart failure, re-hospitalizations for heart failure, pharmacodynamic effects and safety of danegaptide when added to the standard treatment of STEMI patients.

In a Phase I program, including 153 healthy subjects in three studies, danegaptide has been shown to be safe and well tolerated. The POC study is expected to complete in the 2H15.