Zealand advances danegaptide into a Phase II clinical proof-of-concept study for protection against reperfusion injury

• Zealand-discovered peptide has the potential to be the first medicinal therapy to protect against tissue damage following reperfusion
• The first patient has been treated in this Phase II study, conducted at Rigshospitalet in Denmark, a world leading Cardiac Center, and which is expected to enroll a total of 600 patients with myocardial infarction

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) today announces that the first patient has been treated in a Phase II Clinical Proof-of-Concept study of danegaptide. Danegaptide is a novel Zealand invented 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, 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. Rigshospitalet treats more than 40% of Denmark’s approximately 2,500 incidences of STEMI annually and is one of the world’s leading and highly specialized Cardiac Centers.

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.

Commenting on the start of the danegaptide study, Dr. Thomas Engstrøm, PhD, DMSc, Lead Investigator and Chief Physician, the Heart Center, Rigshospitalet, Copenhagen University Hospital, said: “Over the past 15 years we have advanced the treatment of myocardial infarction substantially with the introduction of PCI, including mainly balloon dilatations, saving many patients’ lives. At Rigshospitalet, we have pioneered balloon dilatations as first line treatment in this indication, and today such interventional procedures have become the established standard in most parts of the world. Despite having optimized also the logistics for bringing patients with an MI to the hospital as fast as possible, we still see severe cardiac tissue damage in many patients, which lead to reduced cardiac function and quality of life. The problems are to a large extent caused by reperfusion injuries following the therapeutic intervention, and danegaptide has demonstrated promising potential to help protect against this type of tissue damage. If successful, danegaptide could play a major role in enhancing the clinical outcome of percutaneous coronary intervention (PCI) after an acute MI and deliver important benefits to patients and society.”

Commenting on the announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said: “The commencement of this Phase II Clinical Proof-of-Concept study of danegaptide is a key event for Zealand in-line with our ambition to optimize and increase the value of our proprietary clinical pipeline of peptide candidates. Danegaptide has demonstrated great potential as a novel approach to help reduce cardiac tissue damage with additional potential in other forms of reperfusion injury, and we are excited about the unique opportunity of working with Rigshospitalet to further explore the therapeutic profile of this Zealand peptide.

“Rigshospitalet’s Heart Center is renowned for its clinical expertise. We are proud to be working with this esteemed team which has conducted several other important studies that have helped to change the international guidelines for the treatment of patients with myocardial infarction.”

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.