NeuroVive drops kidney drug after failure
- In an announcement that cut its stock value by 48% on Thursday, Swedish company NeuroVive Pharmaceutical has revealed that its ciclosporin-based CicloMulsion didn't meet its primary objective in the Phase 2 CiPRICS study.
- The drug had no effect in preventing acute kidney injury in patients undergoing open heart surgery. There was a transient but statistically significant increase in the biomarkers P-cystatin C and P-creatinine.
- NeuroVive has discontinued the development of CicloMulsion in acute kidney injury, and will focus its resources on the rest of its pipeline, including a ciclosporin program (NeuroSTAT) in traumatic brain injury and non-ciclosporin based agents in organ protection.
Patients undergoing coronary artery surgery run the risk of kidney damage. Following surgery, around one in 20 people will need post-op dialysis, and they have a much-increased risk of death. The aim for NeuroVive's CicloMulsion was to protect patients having open heart surgery from the risk of acute kidney injury (AKI), and therefore improve their outcomes after potentially-lifesaving surgery.
Unfortunately, the CiPRICS study did not demonstrate this and instead showed a significant increase in levels of the biomarkers P-cystatin C and P-creatinine. While this was only transient, increased levels of plasma cystatin C and plasma creatine can indicate a fall in kidney function.
In what is perhaps somewhat of an understatement, Sponsor-Investigator, Associate Professor Henrik Bjursten of Skåne University Hospital in Lund, Sweden, said: "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," adding that the study has given them further information about ciclosporin treatment in this patient population.
This is the second stumble for CicloMulsion. Back in June 2015, the company reported that the drug didn't meet its composite primary clinical endpoint in the CIRCUS Phase 3 trial in people with a heart attack. At the time, the company stated that it would continue the analysis of the data to see if there were any effects in patient subpopulations, and would continue the study for two years to investigate long-term outcomes. Since then, the indication seems to have dropped off the radar.
NeuroVive is still developing its NVP019 development platform of next-generation cyclophilin inhibitors in preclinical development for organ protection including AKI, and has a last ciclosporin-based drug, NeuroSTAT, in an early Phase 2 trial for traumatic brain injury. It is also working on other projects within mitochondrial medicine.
"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," said CEO Erik Kinnman.
- NeuroVive Pharmaceutical Statement
Follow Suzanne Elvidge on Twitter