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NeuroVive Discontinues - CicloMulsion

October 13, 2016

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NeuroVive Pharmaceutical AB, the mitochondrial medicine company, today announced results from the exploratory clinical phase II study CiPRICS. The results clearly show that patients treated with CicloMulsion prior to open heart surgery experience no benefit compared to placebo in the prevention of acute kidney injury (AKI). As a result, NeuroVive will discontinue the development of CicloMulsion for AKI.

The exploratory CiPRICS study, aimed at preventing AKI in patients undergoing open heart surgery, did not reach the primary objective. In contrast, patients in the active dose group showed a transient, but statistically significant increase in the biomarkers P-cystatin C and P-creatinine compared to placebo. No unexpected tolerability issues were observed and the overall frequencies of serious adverse events were comparable to those observed in the placebo group.

"Since the overall goal for this study was to offer a preventive treatment to patients at risk of developing AKI, the outcome of the study was a disappointment. However, the CiPRICS study has given us very important information about ciclosporin treatment in this patient population. Also, we have appreciated the fruitful and close collaboration with the NeuroVive clinical team", says Sponsor-Investigator, Associate Professor Henrik Bjursten M.D. Ph.D., Department of Cardiothoracic Surgery, Anesthesia and Intensive Care at Skåne University Hospital in Lund, Sweden.

Given the current findings, NeuroVive has decided to discontinue the development of CicloMulsion in AKI and redirect resources to its other development assets. NeuroVive continues to progress its opportunities within mitochondrial medicine, an area with high unmet medical needs. The ciclosporin (NeuroSTAT) development program in traumatic brain injury (TBI) will proceed. NeuroVive will continue development of its unique non-Ciclosporin based cyclophilin inhibitors for organ protection and other unrelated indications. In addition to these high-value possibilities, NeuroVive has several other promising early projects with different, novel modes of action within the area of mitochondrial medicine.

"The CiPRICS study has been excellently conducted by the team, led by Associate Professor Bjursten at Skåne University Hospital, with clear results. Moreover, it has verified the effectiveness of the network partnership model for NeuroVive’s early clinical development”, says NeuroVive’s CEO Erik Kinnman. “We will continue to develop and build our portfolio, and I see several potential upcoming milestone events in our strong and diversified mitochondrial medicine portfolio.”

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