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news.ActivBiotics is planning to conduct a phase III trial of its lead product, rifalazil, as a novel medical treatment for peripheral arterial disease.
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The placebo-controlled trial will evaluate the ability of rifalazil to improve symptoms of peripheral arterial disease (PAD) by assessing improvements in peak walking time.
PAD is a serious complication of atherosclerosis that affects over 11 million Americans and severely limits their ability to carry on normal physical activity. It causes intermittent claudication (pain due to poor circulation and blockage of arteries) which is one of the most frequent causes of debilitating pain and significant disability in individuals aged 55 to 75.
It is well recognized that new therapies are needed to treat this debilitating condition, and the mode of action of rifalazil provides a promising new approach.
At the Trends in Peripheral Vascular Disease Company Showcase & Panel Discussion, Dr Andrew Sternlicht, vice president of medical affairs and corporate development at ActivBiotics, stated: “Our clinical development strategy is based on the clear association between vascular disease and evidence of bacterial infection in patients, which we believe can be treated successfully by our novel anti-chlamydia investigational drug, rifalazil.”
Prior antibiotic studies in atherosclerosis focused largely on disease in the coronary arteries and studied the impact of therapy on clinical events, including myocardial infarctions, recurrent angina, hospitalization, stroke and death.
ActivBiotics is taking a different approach by focusing on symptomatic relief in patients with lower extremity PAD, directly related to bloodflow, rather than life-threatening events.