The interim analysis was performed following AstraZeneca’s decision to expand the size of the “Saint II” trial from 1,700 to 3,200 patients and included safety data from 1,597 patients. AstraZeneca licensed the drug, NXY-059/Cerovive, from US biopharmaceutical company Renovis.
The trial is designed to confirm the positive findings of the “Saint I” trial, which showed NXY-059/Cerovive to demonstrate a statistically significant reduction versus placebo on the primary outcome of disability after an acute ischemic stroke.
No major safety concerns or tolerability problems emerged with NXY-059/Cerovive during the conduct of the Saint I trial, beyond those expected in trials involving patients with acute stroke.
“We interpret this recommendation as further support that NXY-059/Cerovive is well tolerated in acute ischemic stroke patients,” said Dr Corey Goodman, president and CEO of Renovis. “This is an important characteristic of NXY-059/Cerovive in a population of patients previously found to be highly vulnerable to adverse effects of many other drug candidates tested to date.”