NeuroVive Pharmaceutical (STO:NVP) has terminated development of its cyclosporine formulation in acute kidney injury (AKI) after the drug failed to move the needle in a Phase II trial. Investors reacted badly to the news, wiping 50% off the value of NeuroVive for the second time in the past 18 months.
Lund, Sweden-based NeuroVive gave the cyclosporine formulation, branded CicloMulsion, to 155 patients who were about to undergo coronary artery bypass grafting. Researchers thought the drug could protect renal function, a fairly common complication of the surgery, by inhibiting the opening of the mitochondrial permeability transition pore. Studies have linked the opening of the pore to reperfusion-induced necrosis.
The Phase II trial failed to back up the hypothesis. NeuroVive has yet to release a detailed look at the data but has revealed that the study missed its primary endpoint. Worse still, the treatment arm saw a statistically significant increase in cystatin C and creatinine compared to placebo. Physicians look for increases in the biomarkers cystatin C and creatinine to detect when a patient is in the early stages of AKI. The differences between the treatment and placebo arms were temporary.
With the trial generating little, if any, data to suggest CicloMulsion has a future in AKI, NeuroVive has swiftly canned the program. The setback comes less than 18 months after NeuroVive posted weak data from a Phase III trial of CicloMulsion in heart attack patients. NeuroVive thought CicloMulsion would improve outcomes in patients undergoing surgery to reopen their coronary arteries, but the data showed otherwise. On both occasions investors responded by driving down the stock by 50%.
The setbacks leave NeuroVive with one last chance to make a success of its cyclosporine formulation. NeuroVive is testing NeuroSTAT, the formulation of which is identical to CicloMulsion, in a Phase II trial in patients with severe traumatic brain injury. The 20-person, open-label trial is looking at the safety and pharmacokinetics of the drug to set NeuroVive up to run a larger efficacy study down the line. NeuroVive expects to have data from the study next year.
NeuroVive is also talking up the prospects of its non-cyclosporine-based cyclophilin inhibitors and mitochondrial medicine programs with different mechanisms of action. None of these programs are as advanced as the cyclosporine formulation, though. Having gone from having two mid- to late-stage shots on goal to talking up preclinical programs in the space of 18 months, NeuroVive has fallen hard. The stock is down more than 90% since the days preceding the Phase III blowup.