Nuvelo to Discontinue Alfimeprase Development

March 18, 2008

Drugmaker Nuvelo plans to stop development of alfimeprase following disappointing results in a Phase II catheter occlusion trial. 

In the open-label, single-arm trial, alfimeprase restored catheter function in approximately 50 percent of patients at 15 minutes and approximately 60 percent of patients at one hour. While the 15-minute clearance rate represents an improvement over the previous Phase III SONOMA-2 trial, which evaluated a lower dose and concentration of the drug, the clearance rate at one hour fell short of the company’s expectations, according to Nuvelo.

Last June, Bayer HealthCare terminated its agreement with Nuvelo to develop alfimeprase. The announcement came roughly six months after the companies reported two trials of alfimeprase — one in acute peripheral arterial occlusion and the other in catheter occlusion — did not meet their endpoints.