Via Pharmaceuticals, a biotechnology company developing compounds for the treatment of cardiovascular disease, has enrolled the first patient in its Phase 2 clinical trial that utilizes PET with fluorodeoxyglucose tracer (FDG-PET) to measure VIA-2291's ability to reduce vascular inflammation in treated patients. The company also provided an update of its VIA-2291 Phase 2 clinical program.
VIA-2291, a molecule drug that targets inflammation in the blood vessel wall, a disease process in atherosclerosis, being developed as a once-daily, oral drug to potentially decrease the risk of major adverse cardiovascular events associated with inflammation, including heart attack and stroke.
The FDG-PET trial is one of three concurrent, ongoing Phase 2 trials testing VIA-2291 in a variety of clinical settings, according to the San Francisco-based Via. The Phase 2 trial designs are intended to provide visibility to the role of inflammation in cardiovascular disease and the potential of VIA-2291 to address vascular inflammation, Via said.
Via provided the following update for each of its three Phase 2 clinical trials:
- FDG-PET trial: enrolling about 50 patients following a heart attack into a 24-week randomized, double blind, placebo-controlled study, and is expected to be complete during 2008 and data is expected in the first half of 2009. Endpoints in the study include reduction in plaque inflammation following dosing with VIA-2291 as measured with FDG-PET, as well as assessment of standard biomarker measurements of inflammation. The first patient was randomized to treatment at Massachusetts General Hospital in Boston. Mount Sinai Heart in New York City is also participating in the study.
- Carotid endarterectomy (CEA) trial: It has enrolled about 40 patients in the CEA study, and is to gathering additional data by taking advantage of patients currently in the screening and patient recruitment process. Via plans to enroll about 50 patients and expects to report data in the third quarter of 2008. The CEA study is designed to evaluate the efficacy of VIA-2291 in the vessel wall, and has the advantage of providing access to atherosclerotic tissue for direct evaluation of its effect on inflammation, through a panel of assays and histological exams.
- The Acute Coronary Syndrome (ACS) study: has enrolled more than two-thirds of the targeted 200 patients for this trial and data results are scheduled to be released after the data from the CEA trial. The study is designed to establish dose and safety data in patients with ACS who have experienced a recent heart attack, and includes measures of leukotrienes, biomarkers of inflammation as well as medical imaging of the coronary vessel wall to evaluate impact on plaque characteristics.
Lawrence K. Cohen, PhD, chief executive officer of Via, said despite “currently available medications that treat the conditions that increase the risk of these events, these therapies do not treat the underlying inflammation.”