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news.ActivBiotics has announced the results of its Providence-I clinical trial, which evaluated the effect of rifalazil in the treatment of intermittent claudication, associated with peripheral arterial disease. According to the company, the results show that treatment for two months with the experimental antibiotic rifalazil did not result in a significant improvement in walking distance, claudication onset times, or other clinically-relevant parameters of PAD.
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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.”