Astrazeneca reports that it has decided to discontinue development of NXY-059 in acute ischemic stroke based on negative results from its Phase III trial.
“NXY-059’s lack of efficacy in the SAINT trial II is disappointing for stroke patients in view of the significant unmet medical need,” reports Tomas Odergren, vp, global product director for NXY-059.
The SAINT II (Stroke Acute Ischemic NXY-059 Treatment) trial showed that NXY-059 did not meet its primary outcome of a statistically significant reduction in stroke-related disability compared to placebo. Subgroup analyses, including time to treatment, did not demonstrate a treatment benefit.
In addition, NXY-059 did not cause a statistically significant improvement in neurological status versus placebo on the NIH Stroke Scale; there was no evidence of NXY-059 lowering the incidence of symptomatic intracranial haemorrhage when administered with rt-PA; and mortality, the incidence, and profile of adverse events in patients receiving NXY-059 were similar to placebo.
The company’s stock declined more than 7% on the London, Stockholm, and New York exchange.