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news.Isis Pharmaceuticals has begun the Phase II study evaluating the safety and efficacy of ISIS-APOCIIIRx in patients with very high triglycerides.
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The randomized, placebo-controlled study, which will enroll approximately 100 patients who have triglyceride levels of 500mg/dL or higher, is designed to evaluate ISIS-APOCIIIRx as a monotherapy and in combination with fibrates in patients.
Isis development senior vice president Richard Geary said that following the encouraging results observed in Phase I study in healthy volunteers, the company expects to achieve similar triglyceride reductions in patients with very high triglycerides in the Phase II study.
"Assuming these data are replicated, we plan to move rapidly into a Phase 3 study in the most severe patients with triglyceride levels greater than 1,000 mg/dL who have been unable to control their triglyceride levels with currently available treatments," Geary added.
Measurements of triglycerides both before and after eating and apoC-III levels in blood are the endpoints of the dose-response study.
ISIS-APOCIIIRx reduces the protein apoC-III, thereby reducing the triglyceride levels, both of which are independent risk factors for cardiovascular disease.