LEXINGTON, Mass., Feb. 1 /PRNewswire/ -- ActivBiotics, Inc., today announced that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, rifalazil, for the symptomatic treatment of peripheral arterial disease or (PAD). Fast Track designation is reserved for new drugs that demonstrate the potential to address a significant unmet medical need and are intended for the treatment of a serious or life-threatening condition.
In citing reasons for granting the Fast Track designation, the agency noted that current approved treatments for PAD do not target underlying incipient contributors to disease progression, thought to be related to infection with Chlamydia pneumonia. Rifalazil, a bactericidal anti-chlamydial agent, has the potential to eliminate this possible underlying cause of PAD. “We are extremely pleased to receive endorsement of our lead clinical program in the form of this Fast Track approval,” said Steve Gilman, Ph.D., President and CEO. “Since announcing our plans to pursue clinical development of rifalazil in PAD in the 4th quarter of last year, we have aggressively expanded our trial plans and have initiated enrollment in our Phase 3 PROVIDENCE-1 study. We expect Fast Track designation to potentially facilitate development and expedite review of our regulatory submissions as we move towards approval,” added Gilman.
About Peripheral Arterial Disease and the Role of Chlamydia
Over 11 million Americans have peripheral arterial disease, the most common symptomatic presentation of which is intermittent claudication (IC), which presents as leg or buttock discomfort generally brought on with walking or exercise as a result of the limitation in blood supply to the musculature, due to arterial narrowing from atherosclerosis. IC affects 2.5 million Americans and current medical therapies are not widely used because of side effects and contraindications. Over $30 billion dollars is spent annually in the United States in the overall care and treatment of patients with peripheral arterial disease and the costs of annual care of patients with intermittent claudication is over $9,000 per patient. Over 50% of patients with IC have antibodies to Chlamydia pneumoniae, indicative of prior exposure to the bacterium. Presence of these antibodies has been correlated with increased progression of PAD and a higher frequency of clinical complications over time. A small trial previously conducted by independent investigators has demonstrated the utility of anti-chlamydial antibiotics in halting the progression of PAD in selective patients.
About the PROVIDENCE-1 Study
PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients) is a prospective, randomized, double-blind, placebo- controlled, multi-center study of peripheral arterial disease patients with intermittent claudication in which assessments of symptoms, prognostic criteria, and functional capabilities will be made over a one year period. If successful, ActivBiotics intends to use this trial as a pivotal study in its comprehensive Phase 3 program.
About ActivBiotics
ActivBiotics, Inc., located in Lexington, MA is a private biopharmaceutical company focused on the discovery, development and commercialization of breakthrough antibacterials for high-value chronic and infectious disease markets. The Company’s lead product candidate, rifalazil, is undergoing clinical development trials in multiple indications. The Company’s lead pre-clinical compound in a pipeline of novel rifamycins, ABI- 0043, shows significant potential for the treatment of infections caused by Gram-positive pathogens, including Chlamydia pneumoniae, Staphylococcus aureus and MRSA (methicillin-resistant Staphylococcus aureus).
Through its wholly owned subsidiary, Metaphore Pharmaceuticals, the Company is also developing a small molecule compound, as well as the class, that mimic the functions of superoxide dismutase, a beneficial human enzyme. The compound M40403 has been studied in Phase 1 and Phase 2 trials in 680 patients and subjects. Current product development efforts are focused on inflammation and diseases related to oxygen free radical toxicity. For more information on ActivBiotics, please visit our web site at: http://www.activbiotics.com.
ActivBiotics, Inc.
CONTACT: Mr. Glenn Kazo, Chief Business Officer of ActivBiotics,+1-781-372-4864, gkazo@activbiotics.com
Web site: http://www.activbiotics.com//
