The Food and Drug Administration (FDA) has granted Fast Track designation to NeuroSTAT (cyclosporine; NeuroVive Pharmaceutical AB) for the treatment of moderate to severe traumatic brain injury (TBI).

NeuroSTAT prevents the emergence of neurological and functional secondary brain damage after a traumatic injury by inhibiting the mitochondrial permeability transition pore (mPTP). In a phase 2, open label, uncontrolled study (CHIC (Copenhagen Head Injury Ciclosporin), NeuroSTAT demonstrated favorable properties for safety, tolerability, and pharmacokinetics; 16 patients with severe TBI (Glasgow Coma Scale [GCS] score 4-8) were given an initial loading dose of cyclosporine followed by a continuous infusion for 5 days. 

Findings from the study demonstrated NeuroSTAT to be safe and well-tolerated. The study also confirmed that the drug passes the blood brain barrier in patients with TBI and showed signs of clinical effectiveness, as measured by 4 biomarkers (GFAP, NF-L, Tau and UCH-L).

The Company is expected to initiate a phase 2, placebo controlled study to evaluate the efficacy of NeuroSTAT for the prevention of moderate to severe TBI. NeuroSTAT has received Orphan Drug designation both in Europe and the US.

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“The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need. This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study”, said NeuroVive’s CEO Erik Kinnman.

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