Activbiotics Announces Initiation Of Phase II Study In Carotid Atherosclerosis

Simultaneous imaging with high-resolution magnetic resonance imaging and ultrasound facilitates study of rifalazil, a potent anti-chlamydial antibiotic, on carotid plaque and wall thickness changes

LEXINGTON, MA, USA | Feb 14, 2007 |
ActivBiotics, Inc. announced today that patient enrollment has begun in 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 (Randomized Evaluation of Short-Term Rifalazil Treatment on Carotid Atherosclerosis and Intima Media Thickness) is a prospective, randomized, double-blind, placebo-controlled, multi-center 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 and ultrasound of the carotid artery, the major artery supplying blood flow to the brain. Atherosclerotic changes in the carotid artery are strongly correlated with an increased incidence of cardiovascular and stroke events.

Chlamydia pneumoniae infection of the vascular system has long been thought to play a role in accelerating the course of atherosclerotic disease. “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 in these patients,” said Andrew Sternlicht, MD, VP Medical Affairs and Corporate Development. Since Chlamydia infection is believed to increase inflammation in plaque and the arterial wall, this study will use high-resolution magnetic resonance imaging to assess the degree of architectural and anti-inflammatory change brought about by rifalazil.

Additionally, the Company completed enrollment in a Phase III study of rifalazil for the treatment of patients with intermittent claudication, a common manifestation of peripheral arterial disease. PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients) is a multinational, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of rifalazil in 296 patients with intermittent claudication. The Company expects to announce both the six and twelve month data from the PROVIDENCE-1 trial at a major scientific meeting in the fourth quarter of 2007.

About ActivBiotics

ActivBiotics, Inc. is a private biopharmaceutical company located in Lexington, Massachusetts, that is focused on the development and commercialization of novel therapies for the treatment of inflammatory diseases and bacterial infections. The Company's most advance product candidate, rifalazil, has been studied in over 600 patients and volunteers in Phase I-III clinical trials. The Company recently completed enrollment in a Phase III study of rifalazil for the treatment of patients with intermittent claudication, a common manifestation of peripheral arterial disease. In addition, the company is planning to initiate Phase II studies of M40403, a novel anti-inflammatory agent, for the treatment of post-operative ileus and other inflammatory diseases. The Company also has a library of over 1500 compounds with potent antibacterial activity. For more information on ActivBiotics, please visit our web site at:

For information contact:

Glenn Kazo
Chief Business Officer
ActivBiotics, Inc.
Phone: 781-372-4864
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: ActivBiotics, Inc

La Merie Biologics

FREE Weekly News Bulletin

Sign Up

2022 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Sign Up