Zealand Pharma cardiac injury drug misses efficacy endpoint in POC trial

Zealand Pharma's (CPH:ZEAL) danegaptide has missed the primary endpoint in a Phase II cardiac reperfusion injury trial. The failure of the study, which was viewed as a long shot by some analysts, has led to Zealand focusing its resources on other areas of its pipeline.

Zealand CEO Britt Meelby Jensen

Copenhagen, Denmark-based Zealand tested danegaptide in a randomized, placebo-controlled trial of 591 people with severe acute myocardial infarction (AMI). Participants received either a placebo or one of two doses of danegaptide, a gap junction modifier that advanced into Phase II on the strength of the cell protective and antiarrhythmic properties it showed in preclinical tests.

However, Zealand failed to detect the hoped-for protection of cardiac tissue from reperfusion injuries in the danegaptide arms, resulting in the study missing its primary endpoint. Zealand said data from secondary endpoints, such as rehospitalization rates, were "consistent with the results on the primary endpoint." With the top-line data suggesting few, if any, reasons for optimism and Zealand being content that the study was appropriately powered and well run, it looks like the end of the line for danegaptide. 

"We had obviously hoped with this study to demonstrate a therapeutic benefit of danegaptide to patients," Zealand CEO Britt Meelby Jensen said in a statement. "Cardiac damage remains a serious challenge following a heart attack, so in this sense, we are disappointed. … We still think this was a relevant opportunity for us to explore despite the fact that this is a notoriously difficult therapeutic area. … 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."

Shares in Zealand traded down as much as 8% following the news, before regaining ground later in the day. The future of the company is, to a large extent, tied to the success of other drugs, notably the diabetes combo drug that Sanofi ($SNY) has submitted for approval by FDA.

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