Privately-held cerebrovascular diseases company vasopharm has announced that the NOSTRA III traumatic brain injury (TBI) Phase III clinical trial of ronopterin (VAS203) did not meet the pre-specified primary endpoint of improvement in extended Glasgow Outcome Scale (eGOS) at six months after trauma.
The German company has sought to focus on the positive from the results, stressing that a post-hoc analysis reveals clinically-meaningful and statistically-significant improvement in eGOS when ronopterin is infused within 12 hours after trauma.
"We can provide a clear rationale for the beneficial use of ronopterin in patients with moderate and severe TBI"But over the entire patient population, the trial did not meet its primary endpoint, and vasopharm will communicate next steps after discussing these results with competent authorities.
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