Stroke remains one of the toughest areas of drug development, and the two main approaches - neuroprotection and clot busting - both were cast under new clouds last week. Most consequential was the failure of NXY-059 from Renovis Inc. in the Phase III SAINT II trial - one in a long line of disappointments for the concept of neuroprotection in stroke that raises the question of whether the whole idea should be dropped. Of less broad import was the three-day suspension of Phase III enrollment of Paion AG's desmoteplase to review an undisclosed safety signal.
The news also had broader and narrower implications for each company. RNVS now finds itself as a preclinical company, while Paion looks like it will keep its timeline for desmoteplase.
RNVS's NXY-059 news was particularly disappointing, as the compound met the primary endpoint of a significant reduction in stroke-related disability in the Phase III