NuvOx Pharma’s NVX-208 Shows Positive Results in Phase Ib/II Stroke Trial
Positive results of NuvOx Pharma’s NVX-208 in the treatment of stroke have been published at the International Stroke Conference.
The randomized Phase Ib/II trial tested acute ischemic stroke patients given placebo or low, medium, or high doses of NVX-208. The primary endpoint was safety, which was demonstrated at all three dose levels. A secondary endpoint was the modified Rankin Scale (mRS), a measure of how independently patients can live in the weeks and months after the stroke. The high dose group suggested improvement in the mRS at 30 days and 90 days.
The trial was sponsored by the University of Arkansas for Medical Sciences. William “Bill” Culp, MD, the principal investigator on the trial, said, “Such strong safety and promising efficacy results meet our highest hopes for this small trial. Expanded trials are fully warranted.”
Evan Unger, MD, CEO of NuvOx, 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.”
Stroke is the 5th largest cause of death and the leading cause of long-term disability according to the American Heart Association. The CDC estimates the annual cost of stroke treatment as $34 billion.
Acute ischemic stroke is caused by a blockage of blood flow to the brain, often by a blood clot. The brain tissue downstream of the blockage sees reduced blood flow and will die if it does not receive enough oxygen. NVX-208 is designed to improve oxygen delivery to the hypoxic tissue to keep it alive until normal blood flow can be restored.
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