Phase III is a critical step in a drug development process. NeuroVive Pharmaceutical has learnt this the hard way. The Swedish company reported unsatisfactory results of CicloMulsion’s phase III clinical trial in patients having gone through a specific type of heart attack known as STEMI (ST-segment elevation acute myocardial infarction).
The disappointing topline results are expected to delay the commercialization of CicloMulsion, which did not meet its primary clinical endpoint in a topline analysis. NeuroVive is now digging up for results that can clarify the dark horizon of their drug candidate. As Mikael Brönnegård, CEO of the company commented, the company will analyze the full 12-month data set looking for patients that may have benefited from treatment.
These results will help define the next steps of the development and commercialization of CicloMulsion, which is also being tested in a phase II clinical trial to prevent acute kidney injury during heart surgery. However, the STEMI indication seemed to be the faster line to reach the market.
NeuroVive will have to wait for that, if CicloMulsion is definitely commercialized. Failed Phases III are, unfortunately, not unusual. According to David Thomas, Director of Investment and Policy Research at BIO, approximately 51% of the candidates that are already in Phase III end up being approved. Of course, the figure is much lower if we look at earlier stages, as only 17% of Phase II candidates reach the market.
CicloMulsion’s last hope is this 12-month data analysis, although the stock market is not encouraging as NeuroVive’s shares dropped more than 50% due to the poor topline results.