vasopharm GmbH initiates Phase III study (NOSTRA III) to assess ronopternin (VAS 203) for the treatment of traumatic brain (TBI) injury.

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, announced that the first patient has been enrolled in to the NOSTRA III (NO Synthase in TRAumatic Brain Injury) trial � a phase III clinical trial assessing efficacy and safety of ronopternin (VAS 203) for the treatment of moderately to severely injured closed head traumatic brain (TBI) injury patients.

The NOSTRA III European confirmatory multicentre, randomised, double-blind, placebo-controlled trial is planning to enroll 232 patients suffering from a moderate to severe TBI who are hospitalised and have received an intra-cranial pressure probe. The study is designed to evaluate efficacy and safety of VAS 203. In total, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain will participate in the trial. The intravenous administration of VAS 203 will be applied between six and 18 hours after the injury and the infusion period will last for 48 hours. The primary endpoint will be the extended Glasgow Outcome Scale evaluated at six months after the injury. Secondary efficacy assessments include Quality of Life (QOLIBRI) as well as Therapy Intensity Level (TIL) over 14 days after brain injury. Data read-out (final clinical report) of the study is estimated for mid-2019.