The results from the 553-patient phase III peripheral arterial disease (PAD) trial, named SIMPADICO, showed that the study did not reach the primary endpoint of change in maximal treadmill walking distance.
The percentage increase in absolute claudication distance between baseline and 26 weeks in the modified intention-to-treat group (the primary endpoint) was not significantly different between Celacade and placebo groups. Similarly, there were no significant differences in the pain-free treadmill walking distance (initial claudication distance) between the two groups.
However, Vasogen was keen to point out that Celacade significantly reduced high sensitivity C-reactive protein (hs-CRP), a pre-specified endpoint and a widely recognized marker of systemic inflammation associated with increased cardiovascular risk, including heart failure, stroke, and heart attack.
“We are obviously disappointed that Celacade was not shown to improve walking distance in PAD, one of the most difficult endpoints in which to demonstrate a therapeutic benefit,” stated Dr Jeffrey Olin, professor of medicine at the Mount Sinai School of Medicine, and principal investigator and chairman of the steering committee for the SIMPADICO trial. “It is very interesting to note, however, the finding of a significant reduction in C-reactive protein.”
“Given this finding, and the fact that otherwise successful therapies have failed to demonstrate a walking distance improvement in PAD, I look forward to the results of the ongoing trial of Celacade in chronic heart failure, where inflammation plays an important role,” he continued.
Celacade was shown to be well tolerated in this patient population, who were receiving standard-of-care medications for atherosclerosis and PAD, including statins, beta-blockers, anti-platelet agents, and ACE-inhibitors.