Bayer/Nuvelo's alfimeprase misses Ph III endpoints, enrollment stopped

US drugmaker Nuvelo and German drug major Bayer says that their co-developed drug candidate alfimeprase missed its primary endpoint in a Phase III trial in acute peripheral arterial occlusion (PAO). The agent failed to achieve sufficient avoidance of open vascular surgery within 30 days of treatment. The companies also reported that a Phase III trial in catheter occlusion (CO), known as SONOMA-2 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-2), did not meet the endpoint of restoration of function at 15 minutes. In addition, these studies did not meet key secondary endpoints and the companies have temporarily suspended enrollment in these ongoing Phase III evaluations until further analyses and discussions with outside experts and regulators are complete.