The prospective, randomized, double-blinded international study was done on an outpatient basis with the primary endpoint being a change in baseline peak walking time, comparing those given rifalazil against those given a placebo. The study enrolled 297 consenting men and women (40-80 years old) with diagnosis of intermittent claudication due to PAD who also had high levels of antibodies to C. pneumoniae.
Steven Gilman, chairman and CEO of ActivBiotics, said: “We are clearly disappointed with the low efficacy signal seen in rifalazil-treated patients which was only 4% greater than placebo, a difference which was not statistically significant. On the other hand, we are pleased that the population demographics, low placebo response and overall low variability in this study provided a very clear cut answer.”