German biopharmaceutical company vasopharm has closed enrolment in the Phase III NO Synthase in Traumatic Brain Injury (NOSTRA III) clinical trial of Ronopternin (VAS203) being conducted in Europe.
VAS203 is an allosteric inducible nitric oxide synthase (iNOS) inhibitor designed to reduce excessive production of NO caused by acute activation of iNOS. The drug acts on cerebral blood vessels, as well as cerebral tissue.
In preclinical studies with controlled cortical impact, VAS203 demonstrated encouraging effects on increased intracranial pressure (ICP), which is responsible for the TBI consequences.
The drug also had positive effects on neurological outcome, which was determined using behavioural tests.
NOSTRA III is being performed to evaluate the safety and efficacy of VAS203 in treating 220 moderately to severely injured closed head TBI patients at 35 trauma centres across Europe.
Enrolment for the study was commenced in September 2016. The secondary efficacy endpoints are quality of life (QOLIBRI) and therapy intensity level (TIL) for 14 days following the brain injury.
Vasopharm CEO Christian Wandersee said: “We are delighted to have reached such a significant milestone. We look forward to delivering top-line results, which we hope will confirm the highly significant data seen in our NOSTRA II trial.
“This will allow us to deliver an essential therapeutic option to both physicians and patients who experience the devastating and life-long consequences of TBI, for which there is no existing drug treatment.”
With an extended Glasgow Outcome Scale (eGOS) six months post-trauma evaluation required, the last visit of the last patient is expected to take place in June.
The company is set to report headline results by the end of the year.