ACTIVBIOTICS INITIATES STUDY IN CAROTID ATHEROSCLEROSIS

ActivBiotics has begun enrolling patients into a Phase II study examining the effect of rifalazil, a potent anti-chlamydial antibiotic, on atherosclerotic changes in the carotid artery. The RESTORE-IT trial is a prospective, randomized, double-blind, placebo-controlled, multicenter study of patients with a clinical history of atherosclerotic disease.

Patients will receive either once-weekly treatment with ActivBiotics' investigational anti-chlamydial antibiotic, rifalazil, or placebo, over a 12-week period, and will be followed for 18 months with serial magnetic resonance imaging (MRI) and ultrasound of the carotid artery. Atherosclerotic changes in the carotid artery are strongly correlated with an increased incidence of cardiovascular and stroke events, according to the company.

Chlamydia pneumoniae infection of the vascular system has long been thought to play a role in accelerating the course of atherosclerotic disease, ActivBiotics said. Since Chlamydia infection is believed to increase inflammation in plaque and the arterial wall, this study will use high-resolution MRI to assess the degree of architectural and anti-inflammatory change brought about by rifalazil.

"Preclinical and clinical studies have demonstrated that rifalazil has high anti-chlamydial potency and hence the potential to have a meaningful impact on the progression of atherosclerotic disease," Andrew Sternlicht, vice president of medical affairs at ActivBiotics, said.