vasopharm Announces Last Patient Last Visit in NOSTRA III Traumatic Brain Injury Clinical Trial
Top-line results expected Q4 2020
vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, is pleased to announce today that the Last Patient Last Visit (LPLV) in its phase 3 NOSTRA III clinical trial occurred on June 17, 2020.
The NOSTRA trial (NO Synthase in TRAumatic Brain Injury) is a pivotal European trial assessing the efficacy and safety of Ronopterin (VAS203) for the treatment of moderately to severely injured closed head traumatic brain (TBI) injury patients. Current approaches to the treatment of acute TBI focus on short term patient mortality and have no significant impact on reducing long-term physical and cognitive deficits. The NOSTRA III trial is a placebo-controlled, randomised, double-blind, multi-centre study in five countries at 29 investigational sites in Austria, France, Germany, Spain and the UK. 223 patients have been enrolled on the trial. The company remains on schedule to deliver headline data in Q4 2020.
Frank Tegtmeier, PhD, Chief Scientific Officer of vasopharm, commented:
“We are very pleased to have reached another significant milestone for our lead drug candidate Ronopterin. It is the first drug which targets both blood vessels and tissue of the brain and represents a completely novel pharmacological approach. We are deeply grateful to the investigators and their teams who continued their trial related work in an outstanding manner, especially during these challenging times of Covid-19.”
Prof. Dr. Erich Schmutzhard, Medical University of Innsbruck, Austria and Chief Investigator for the trial said:
“vasopharm’s innovative and differentiated approach has the potential to offer new, advanced treatment options to acute TBI patients and we are looking forward to evaluating this promising and unique target. It is very exciting to see the completion of the NOSTRA III trial and we believe VAS203 will provide physicians with a real opportunity to reduce long-term sequelae of TBI, thereby improving long-term outcomes of TBI patients.”
NOSTRA III’s primary endpoint is the extended Glasgow Outcome Scale (eGOS) at six months post-trauma; secondary endpoints include Quality of Life (QOLIBRI) at six months post-trauma, QOLIBRI overall scale (QOLIBRI-OS) at three and six months post trauma, eGOS at three months post-trauma, Therapy Intensity Level (TIL) over 14 days after start of treatment and the number of craniectomies.
*Efficacy of Ronopterin (VAS203) in patients with moderate and severe traumatic brain injury (NOSTRA phase III trial): Study protocol of a confirmatory, placebo controlled, randomised, double-blind multi-centre study. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3965-4