Renovis, Inc. announced that a pivotal phase III study of NXY-059 (Saint II) conducted by its exclusive licensee, AstraZeneca, did not demonstrate a statistically significant reduction on the primary endpoint of stroke-related disability in patients treated with NXY-059, as assessed versus placebo using the modified Rankin Scale.
On a secondary endpoint in the Saint II study, treatment with NXY-059 did not result in a statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale (NIHSS). There was also no evidence of NXY-059 lowering the incidence of symptomatic intracranial haemorrhage when administered with the approved thrombolytic agent, rt-PA. The incidence and profile of adverse events in patients in Saint II receiving NXY-059 was similar to placebo. The mortality rate was also comparable in the treatment and placebo groups.
"We are obviously very disappointed by the lack of efficacy shown by NXY-059 in the Saint II study," commented Corey S. Goodman, Ph.D., president and chief executive officer of Renovis. "Stroke is an area of enormous medical need and we had hoped that NXY-059 might become an important new treatment option for patients and physicians. Unfortunately, the data are clear and although we will continue to review the results from Saint I and Saint II, we understand AstraZeneca's decision to discontinue development of NXY-059."
Dr. Goodman continued, "We have managed our resources carefully so that Renovis is in a strong financial position to continue our unpartnered drug discovery programs targeting major medical needs in inflammatory and neurological diseases. In addition, our partnerships with Pfizer and Genentech continue on track. We expect that a compound from our collaboration with Pfizer to develop VR1 antagonists for pain will enter the clinic in 2007."