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news.Via Pharmaceuticals has completed patient enrollment in its carotid endarterectomy study, the first of three Phase II trials investigating VIA-2291, the company's lead product candidate.
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The carotid endarterectomy (CEA) study enrolled 50 patients and is designed to provide direct evaluation of VIA-2291’s effect on inflammation by analyzing plaque removed from the carotid arteries of patients treated with VIA-2291 or placebo. Patients who are diagnosed with carotid artery blockage are treated for three months with either VIA-2291 or placebo and then undergo a CEA procedure. The trial will also measure standard serum biomarkers of inflammation to measure reduction of inflammation in treated patients.
The Phase II program of VIA-2291 includes three concurrent, ongoing trials testing the compound in a variety of clinical settings. In addition to the CEA study, Via is conducting an acute coronary syndrome (ACS) trial, designed to establish dose and safety data in patients with acute coronary syndrome who have experienced a recent heart attack or stroke, and includes measures of leukotrienes, biomarkers of inflammation as well as medical imaging of the coronary vessels in a subset of patients, to evaluate the impact of VIA-2291 on plaque characteristics. The FDG-PET study is the third Phase II clinical trial. Endpoints in this study include reduction in plaque inflammation following dosing with VIA-2291 as measured with state-of-the-art FDG-PET imaging technology, as well as assessment of standard biomarker measurements of inflammation.
VIA-2291 is a potent small molecule drug that targets inflammation in the blood vessel wall, a primary disease process in atherosclerosis. It is being developed as a once-daily, oral drug to potentially decrease the risk of major adverse cardiac events associated with inflammation, including heart attack and stroke. VIA expects to present top line CEA study results in the third quarter of this year. Enrollment is also nearing completion for the company’s ACS Phase II trial and data is expected to follow soon after the CEA data.
Lawrence Cohen, CEO of Via Pharmaceuticals, said: “The information from the CEA, ACS and FDG-PET studies is designed to provide the weight of evidence regarding the effectiveness of VIA-2291 and to support the further development of our lead compound.”