The independent safety committee has endorsed moving on to the next dose level without any safety issues, following the treatment of 10 of 20 patients in the ongoing clinical phase IIa study for traumatic brain injury with NeuroVive’s drug candidate NeuroSTAT. Consequently, the study will continue as planned and move on to the next dosage group.
The ongoing CHIC study (Copenhagen Head Injury Ciclosporin Study) is an open-label, non-comparative clinical phase IIa study enrolling a total of 20 patients divided into two different dosage groups, where NeuroVive’s drug candidate NeuroSTAT is being evaluated for the treatment of patients with traumatic brain injury. The study is being conducted at the Department of Neurosurgery at Rigshospitalet, University of Copenhagen, Denmark, with Jesper Kelsen as principal investigator.
The study’s first dosage group of 10 patients has now been treated with NeuroSTAT at the lower dose, and an interim analysis has been completed by an independent safety committee in order to evaluate the treatment’s safety profile. The analysis includes an evaluation of blood concentrations of cyclosporin A (the active substance in NeuroSTAT) and changes in intracranial pressure and blood samples collected to analyse possible organ injury. According to the analysis, the low-dose treatment is judged to be safe and the study will now continue as planned with the higher dosage group including 10 additional patients.
“We have now obtained important safety data on what we have designated to be the lower dose of NeuroSTAT for treating patients with traumatic brain injury. We can now move on to include patients that will be treated with a higher dose. This means that the study has reached an important milestone in the clinical trial programme of NeuroSTAT,” commented NeuroVive’s chief executive officer Mikael Brönnegård.