Mitochondrial medicine company NeuroVive Pharmaceutical AB (STO: NVP)(OTCQX: NEVPF) announced on Friday the approval by the US Food and Drug Administration (FDA) of NeuroVive's IND (Investigational New Drug) application, enabling clinical studies in the US with the company's drug candidate NeuroSTAT in development for treatment of moderate to severe traumatic brain injury (TBI).
In the US, an FDA approved IND application is needed in order for not yet marketed investigational drugs to be used in clinical studies. This IND application has to contain detailed information about pharmacology and toxicology studies, manufacturing information, protocols for proposed clinical studies and information on the qualifications of the clinical investigators, to assure that research subjects will not be subjected to unreasonable risk.
According to the company, NeuroSTAT's safety, tolerability and pharmacokinetic profile have previously been evaluated in a phase II clinical study in Copenhagen (the CHIC study). Samples from the patients were also analysed for brain cell damage biomarkers which gave a first signal of clinical effect.
NeuroSTAT has orphan drug designation in both Europe and the US.
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