In the open-label, single-arm Phase II trial (Sonoma-3), alfimeprase restored catheter function in approximately 50% of patients at 15 minutes and approximately 60% 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 alfimeprase than the Sonoma-3 trial, the clearance rate at one hour fell short of the company’s expectations. CathfloActivase, the product currently on the market for catheter occlusion (CO), has been shown to restore catheter function in more than 80% of occluded catheters within two to four hours.
As a result of the decision to discontinue alfimeprase clinical development, Nuvelo will restructure to make additional resources available for its other R&D programs. In connection with the restructuring, the company is reducing its work force by approximately 40 full time equivalents, consisting of a combination of employees and contractors. As part of the reorganization, Michael Levy, executive vice president of R&D, will be leaving the company.
Ted Love, chairman and CEO of Nuvelo, said: “The value proposition for alfimeprase in CO was to restore catheter function with similar efficacy to CathfloActivase, but in a much shorter time frame. We did not see the robust increase in activity or dose response expected with the significantly increased dose and concentration we tested in the Sonoma-3 trial. We have conducted high-quality, comprehensive development of alfimeprase and are confident that our decision to shut down this program is appropriate for our business.”