German biopharmaceutical company vasopharm has begun enrolling patients in its Phase III no synthase in traumatic brain injury (NOSTRA III) trial of Ronopterin (VAS203) to treat moderately to severely injured closed head traumatic brain (TBI) injury patients.
VAS203 is an investigational nitric oxide synthase inhibitor developed as an analogue of the natural co-factor biopterin, and considered responsible for the generation of nitric oxide by the nitric oxide synthase (NOS) family of enzymes.
It causes a selective down regulation of inducible NOS (iNOS) without significantly affecting the functions of other NOS enzymes.
iNOS is considered responsible in the cascading of damaging sequellae after a traumatic brain injury.
The NOSTRA III European trial has been designed as a multicentre, randomised, double-blind, placebo-controlled study intended to test the safety and efficacy of VAS203.
It will enrol around 232 patients afflicted with moderate to severe TBI who are hospitalised and have been treated with an intra-cranial pressure probe.
During the trial, VAS203 will be administered intravenously between six and 18 hours post-injury and the infusion period will last for two days.
The secondary efficacy endpoints of the trial are to determine the quality of life (QOLIBRI) and therapy intensity level (TIL) for 14 days following the brain injury.
Vasopharm CEO Christian Wandersee said: "The phase III trial is a key test to confirm our belief in the clinical efficacy of Ronopterin (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."
The company is expecting the final clinical report of this study in 2019.