NeuroVive Pharmaceutical issued the following announcement on May 10.
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the US Food and Drug Administration, FDA, has approved 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. The 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.
"We're truly excited about the approved IND, which is also NeuroVive's first. It's a highly important milestone and a great recognition for the project, and also valuable in our discussions with possible external partners regarding non-dilutive funding and the continued development of NeuroSTAT," said NeuroVive's CEO Erik Kinnman.
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 analyzed for brain cell damage biomarkers which gave a first signal of clinical effect. NeuroSTAT has orphan drug designation in both Europe and the US.
This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CEST on 10 May 2019.
Original source can be found here.