vasopharm completes patient enrollment for Phase III Traumatic Brain Injury Trial (NOSTRA)
Top-line results expected end of 2020
vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, is pleased to announce that enrolment into the pivotal European NOSTRA III (NO Synthase in TRAumatic Brain Injury) clinical trial is completed. vasopharm remains on track to deliver headline data by end of 2020.
NOSTRA III is a 220 patient Phase III clinical trial assessing efficacy and safety of Ronopternin (VAS203) for the treatment of moderately to severely injured closed head traumatic brain (TBI) injury patients. The study is being conducted in 35 leading European trauma centres. In accordance with the study protocol which requires an evaluation of the extended Glasgow Outcome Scale (eGOS) six months post-trauma, the company anticipates last patient – last visit in June 2020 and full clinical data analysis by end of 2020. The full study protocol has been published in the peer-reviewed journal ‘Trials’ *.
Frank Tegtmeier, PhD, Chief Scientific Officer of vasopharm, commented:
“We are extremely pleased to have completed enrolment into our pivotal study, NOSTRA III. Throughout the trial we have insisted on adherence to extremely rigorous inclusion-exclusion criteria which has resulted in slower recruitment than initially projected. I would like to thank the investigators and their teams in all of our study sites, for their huge commitment and dedication in helping us to reach this important milestone.”
Christian Wandersee, Chief Executive Officer of vasopharm, added:
“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.”
Traumatic Brain Injury is the leading cause of death and disability among young adults in the developed world. Annually, within the US alone, head trauma is the cause of about two million emergency room visits, roughly 475,000 hospital admissions, nearly 52,000 deaths and approximately 80,000 cases of severe long-term disability (e.g. functional and cognitive disorders, learning disabilities). Direct costs attributed to the treatment of TBI exceed $10bn p.a. in the US alone.
*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