LifeCycle Pharma A/S, an emerging specialty pharmaceutical company, has completed patient enrolment in its phase II clinical trial of LCP-AtorFen for the treatment of mixed dyslipidemia, which commenced in July 2007 to compare LCP-AtorFen, the company's fixed-dose combination product candidate of atorvastatin and lowest dose fenofibrate, with Lipitor (40 mg atorvastatin calcium tablets) and Tricor (145mg fenofibrate tablets).
In addition, the company has initiated a 52-week, open-label extension study in order to capture additional safety and efficacy data on the use of LCP AtorFen in patients with mixed dyslipidemia.
"Total patient enrolment in the LCP-AtorFen phase II clinical trial exceeded our expectations. We look forward to receiving top-line data and the results of our extension study in the coming months and year," stated Michael Beckert, MD, chief medical officer, LCP. "With the successful penetration and adoption of marketed cardiovascular combination therapies such as Vytorin, Advicor, Exforge and Lotrel, we believe that the uptake of statin/fibrate combination therapies, such as LCP-AtorFen, will follow. LCP-AtorFen's once-daily, fixed dose tablet profile could offer patients a more convenient alternative to the current treatment of two tablets with varying doses".
The 12-week phase II multicentre, double-blind, randomised, active controlled clinical trial enrolled a total of 220 patients (targeted 200 patients) with mixed dyslipidemia, across 14 centres in the US. The clinical trial was designed so that after a wash-out phase, eligible patients were randomised on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin (Lipitor) or fenofibrate (Tricor) for 12 weeks. At the conclusion of the clinical trial each eligible patient will be given the opportunity to rollover to, and participate in, the extension study whereby patients will be provided a once-daily tablet of LCP-AtorFen for an additional 52 weeks.
The company expects to report top-line results from the phase II clinical trial at the end of the first quarter or early in the second quarter of 2008 (late 1Q08 / early2Q08). Primary endpoints include assessing the non-HDL cholesterol and triglyceride lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus atorvastatin (Lipitor). Secondary endpoints include assessing the non-HDL and LDL cholesterol lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus fenofibrate (Tricor).
LCP-AtorFen is a fixed-dose combination therapy for the treatment of high cholesterol levels using atorvastatin (the active ingredient of Lipitor) and the lowest dose of fenofibrate without food effect. LCP-AtorFen is designed as a once-daily tablet for the treatment of high cholesterol levels and to address three primary cardiovascular risk factors: low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides (TG).
The aggressive treatment of risk factors for heart disease is becoming more and more common in modern medicine and in this regard both statins, such as Lipitor, and fenofibrates, such as Tricor, have been significant new therapeutic tools. Statins are the most effective drugs to reduce elevated LDL-C while fenofibrates are effective at lowering TG concentrations and increasing HDL-C. Numerous clinical trials have shown the added benefits of combinations of both fenofibrates and statins when compared to monotherapy, particularly in patients with type II diabetes and the metabolic syndrome.
LCP is an emerging specialty pharmaceuticals company that, through innovative technologies, is able to rapidly develop a portfolio of differentiated products to meet the unique needs of key therapeutic markets and patient populations. This includes products for immunosuppression, specifically organ transplantation, and to combat certain cardiovascular diseases. By using its unique and patented delivery technology, MeltDose, LCP is able to develop drugs with enhanced absorption and thereby increased bioavailability.