LifeCycle Pharma to initiate Phase II clinical trial of LCP-AtorFen

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LifeCycle Pharma A/S initiates a Phase II clinical trial program using LCP-AtorFen, a fixed-dose combination of atorvastatin and fenofibrate, for the treatment of high cholesterol levels. LCP-AtorFen will be a powerful and safe treatment of high cholesterol levels, addressing three primary cardiovascular risk factors: low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides (TG).

The trial is designed as a double-blind, randomized, active controlled study to compare LCP-AtorFen with Lipitor(R) and Tricor(R) in around 200 patients with Mixed Dyslipidemia over 12 weeks followed by an open-label extension study for one year.

"This trial is supposed to give us substantial guidance for planning a Phase III program in different patient populations", said Dr. Michael Beckert, chief medical officer at LifeCycle Pharma.

"This is the start of an exciting clinical development program. LCP-AtorFen, the combination of one of the most potent and safe statins (atorvastatin) plus a safe and efficacious fibrate (fenofibrate), opens the opportunity to address all angles of the atherogenic triad (LDL-C, HDL-C and Triglycerides) in one single pill", said Dr. Michael Davidson, clinical professor at University of Chicago Pritzker School of Medicine, executive medical director of Radiant Research and one of the clinical investigators for this study.