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news.LifeCycle Pharma has announced positive results from the company's Phase II clinical program with LCP-AtorFen, a fixed-dose combination product of atorvastatin and fenofibrate for the treatment of mixed dyslipidemia.
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According to Michael Beckert, chief medical officer of LifeCycle Pharma, the Phase II clinical program confirmed that LCP-AtorFen was safe and well-tolerated. In addition, the study showed significantly better effect of LCP-AtorFen combination therapy for HDL-C and Triglycerides versus atorvastatin (Lipitor) monotherapy, and for non-HDL, LDL-C, Triglycerides and Total Cholesterol versus fenofibrate monotherapy.
The trial was designed as a double-blinded, randomized and actively controlled study to compare LCP-AtorFen with Lipitor and Tricor in approximately 220 patients with mixed dyslipidemia over 12 weeks, followed by a 52-week open-label extension study initiated in the fourth quarter of 2007. LCP-AtorFen is a convenient single tablet with a once-daily dosage profile and is without food effect.
LifeCycle Pharma is preparing for the initiation of a Phase III clinical program which is expected to start during the second half of 2008. LifeCycle Pharma intends to develop a partnership with an established pharmaceutical company to provide funding for the Phase III clinical studies, which will be conducted in approximately 1,000 dyslipidemia patients.