NeuroVive tanks after PhIII flop sets back approval plans

A Phase III trial of NeuroVive Pharmaceutical's (STO:NVP) CicloMulsion in heart attack patients has missed its primary endpoint. And while NeuroVive is still hoping to find positives in a full analysis of the 12-month data, the setback nonetheless wiped more than 50% off the company's share price.

NeuroVive CEO Mikael Brönnegård

The best-case scenario now is that NeuroVive's commercialization plans are delayed. For that to happen, the Lund, Sweden-based drug developer will need to find solid indications of efficacy that aren't apparent in the topline data. The information released so far shows CicloMulsion failed to improve outcomes for ST-segment elevation acute myocardial infarction (STEMI) patients in the 12 months after treatment. NeuroVive assessed the patients against a composite primary endpoint made up of data on mortality, hospitalization for heart failure and left-ventricular remodeling.

Each of the 975 participants was given either CicloMulsion or a placebo before undergoing surgery to reopen the coronary artery, a common procedure performed to restore blood flow. NeuroVive expected CicloMulsion to improve patient outcomes by protecting mitochondria and consequently preventing the cell deaths that occur in the days following a heart attack. With the initial trial data failing to support the thesis, attention has now turned to a full analysis in an attempt to slice and dice toward a positive result.

"Analysis of the full 12-month data set will provide us with more information in regard to which patients may have benefited from treatment with CicloMulsion," NeuroVive CEO Mikael Brönnegård said in a statement. The analysis will look at subpopulations of patients and individual components of the primary endpoint. NeuroVive expects to complete the full analysis in the third quarter, at which time it will decide whether it will continue developing CicloMulsion in STEMI patients.

NeuroVive is still developing CicloMulsion in other indications--a Phase II trial on kidney function is active--but STEMI represented its best near-term opportunity to bring the drug to market. The odds of such a fast approval happening have lengthened impacts on Sanofi ($SNY), which just last week struck a deal to develop CicloMulsion in South Korea. NeuroVive is keeping schtum about the effect of the trial data on the collaboration until it has wrapped up the full analysis. 

- read the release
- and accompanying Q&A (PDF)

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