NuvOx Pharma has reported positive results from the Phase Ib/II clinical trial of NVX-208 for the treatment of acute ischemic stroke.
The US-based biotechnology company develops products using odecafluoropentane emulsion (DDFPe), which flows through the lungs and captures oxygen when administered intravenously.
DDFPe then flows through the blood and offloads the oxygen to hypoxic tissue in order to keep it alive until normal blood flow is restored.
The randomised Phase Ib/II trial evaluated the low, medium and high doses of NVX-208, with all three meeting the primary endpoint of safety.
Modified Rankin Scale (mRS) was used as a secondary endpoint to measure how independently patients could live after their stroke. mRS was observed to improve at 30 days and 90 days in the high dose arm.
The trial was funded by the University of Arkansas for Medical Sciences.
NuvOx Pharma CEO Evan Unger said: “NVX-208 shows immense potential to improve patient outcomes in this area of high unmet need. NuvOx is planning further clinical trials to build on these positive results and deliver a first-in-class drug for oxygen delivery.”
The company secured approval from the US Food and Drug Administration (FDA) in Jaunary last year to conduct a Phase II trial of its DDFPe product in 60 ischemic or hemorrhagic stroke patients.
The trial is designed to assess the product’s ability to deliver oxygen to parts of the brain affected by stroke. It will monitor the oxygenation of the brain and stroke severity using magnetic resonance imaging (MRI).
Strokes affect 795,000 people annually in the US and result in 40,000 deaths and a $34bn cost burden.