Results from the Sonama-2 trial show that alfimeprase restored catheter function in patients with occluded catheters within 15 minutes in 34.3% of patients in the alfimeprase group versus 21.6% in the placebo group. While alfimeprase restored catheter function in a greater number of subjects than placebo, it did not meet its primary endpoint by achieving a p-value of less than or equal to 0.00125 at 15 minutes. At 30 minutes post first or second infusion, catheter function was restored in 52.7% of patients treated with alfimeprase versus 30.4% in the placebo group.
Sonama-2 was a multi-center, multi-national, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of alfimeprase in subjects with occluded catheters. Subjects were randomized in a 2:1 ratio to receive either 3 milligrams of alfimeprase or placebo. The study drug was delivered in a total volume of 2 milliliters. The primary efficacy endpoint was restoration of catheter function at 15 minutes post first infusion. The pre-specified p-value for this endpoint was less than or equal to 0.00125.
Michael Levy, executive vice president of research and development for Nuvelo, said: “We are currently enrolling patients in the Sonama-3 trial to evaluate whether a higher and more concentrated dose of alfimeprase will improve clot dissolution rates while maintaining the favorable risk benefit profile seen in Sonama-2. We look forward to sharing top-line data from this trial in the first half of 2008.”