AsianScientist (Sep. 3, 2011) – Dr. Reddy’s Laboratories announced this week the initiation of dosing with DRL-17822 in patients with diagnosis of type II dyslipidemia.
DRL-17822 is a selective, orally bioavailable inhibitor of cholesteryl ester transfer protein (CETP), for the treatment and/or prevention of dyslipidemia, atherosclerosis and associated cardiovascular disease.
The current study is being conducted under a CTA in a number of countries in Europe.
The objective of the study is to evaluate the efficacy and safety of DRL-17822 in patients with Type-II dyslipidemia. This is a randomized, double blind, placebo controlled, parallel group study in 160 subjects. The primary outcome measure is to assess the elevation in HDL cholesterol and reduction in LDL cholesterol from baseline to end of treatment compared to placebo. Three doses (50, 150 & 300 mg) of DRL-17822 given once daily for four weeks will be evaluated during this study.
Three human Phase I studies with DRL-17822 had already been conducted in Europe, where DRL-17822 was shown to be safe and well tolerated. In these studies, the proof of mechanism had been demonstrated by dose-dependent inhibition of plasma CETP activity as well as by significant increase in HDL cholesterol and decrease in LDL cholesterol levels.
Cardiovascular disease is a leading cause of death worldwide, with coronary heart disease (CHD) as the leading cause of morbidity and mortality. Stabilization and/or regression of atherosclerotic plaques may have a major impact on reducing the risk of acute coronary events. Low-density lipoprotein cholesterol lowering agents, primarily the statins, are the current mainstay in the pharmacological management of dyslipidemia. However, significant residual cardiovascular risk remains despite use of statins.
Epidemiological and observational studies demonstrate that reduced high density lipoprotein cholesterol levels are a strong, independent predictor of CHD, suggesting that raising HDL cholesterol levels might help to reduce the cardiovascular risk. One approach to raise HDL level has been inhibition of CETP activity, which is believed to lead to a CHD risk reduction.
“We are excited to continue to advance our CETP program and look forward to the data from our Phase II study. This class of therapy could transform the treatment of CHD and DRL 17822 is in a position to be one of the front-running products in the class,” said Dr. K. Anji Reddy, Founder Chairman, Dr. Reddy’s Laboratories.
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Source: Dr. Reddy’s.
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