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Vasopharm enrols first patient in phase III traumatic brain injury trial
8 September 2016 • Author: Niamh Louise Marriott, Digital Content Producer
Vasopharm‘s ronopternin (VAS203) will be evaluated for its safety and efficacy as the first patient is enrolled into the nostra phase III (NO Synthase in TRAumatic Brain Injury) trial – a clinical study to assess whether the drug can be used as a initial treatment for moderately to severely injured closed head traumatic brain (TBI) injury patients.
The intravenous administration of VAS203 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.
Traumatic brain injury (TBI) is the leading cause of death and disability among young adults and occurs when a sudden trauma causes damage to the brain. Every year, over 1,600,000 patients sustain a traumatic brain injury in the EU, and 70,000 of these die, with a further 100,000 being left disabled.
Following success in Phase II
VAS203 is an investigational Nitric Oxide Synthase inhibitor, which demonstrated statistically significant improvements to both short term (Therapy Intensity Level) and long term (extended Glasgow Outcome Scale, 6 months and 12 months) measures of treatment efficacy in a clinical phase II trial.
The nostra III European confirmatory multicentre, randomised, double-blind, placebo-controlled trial is planning to enrol 232 patients suffering from a moderate to severe TBI who are hospitalised and have received an intra-cranial pressure probe.
In total, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain will participate in the trial.
Vasopharms CEO’s Christian Wandersee, said, “We welcome the recruitment of the first patient in to this pivotal phase III trial. The phase III trial is a key test to confirm our belief in the clinical efficacy of ronopternin (VAS203) and its role in the treatment of moderately to severely injured closed head traumatic brain injury patients and leads us another step closer to bringing a drug for a highly unmet need to market. We believe VAS203 will provide physicians with a real opportunity to improve long-term outcomes for patients with this devastating condition.”
Final results estimated mid-2019.
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