Dr Reddy's starts Phase-II trials of DRL-17822 molecule

B D Narayankar

Press Trust of India

Bangalore, Sept 2: Drug firm Dr Reddy's Laboratories today said it has started a Phase-II study in Europe to test the safety and efficacy of its'DRL-17822'molecule, which is aimed at treating coronary heart diseases.

"The current study is being conducted under a CTA (clinical trial authorisation) 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, "Dr Reddy's said in a statement.

Phase-II clinical trials are conducted on a larger sample of human subjects (20-300) to assess how well a drug works.

DRL said that Phase-II trials for 'DRL-17822' are being carried out on 160 subjects to assess the elevation in HDL cholesterol and reduction in LDL cholesterol.

The reaction of clinical trial subjects to three doses (50 mg, 150 mg and 300 mg) of'DRL-17822'given once daily for four weeks will be evaluated during this study, it said.

"This class of therapy could transform the treatment of coronary heart disease and'DRL 17822'is in a position to be one of the front-running products in the class,"Dr Reddy's Laboratories Founder Chairman K Anji Reddy said.

Three human Phase-I studies (on select small human sample) with DRL-17822 have already been conducted in Europe, where it was shown to be safe and well-tolerated, it added.

These studies have shown that DRL-17822 leads to a significant increase in high-density lipoprotein (HDL) cholesterol and a decrease in low-density lipoprotein (LDL) cholesterol levels, Dr Reddy's said.

Cardiovascular diseases are a leading cause of death among men and women worldwide. Among cardiovascular disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause of morbidity and mortality.

Studies have demonstrated that reduced HDL levels are a strong, independent predictor of CHD, suggesting that raising HDL cholesterol levels might reduce the risk of cardiovascular diseases, the company said.


Links

http://www.thehindubusinessline.com/incoming/article2418114.ece

http://www.moneycontrol.com/news/business/dr-reddys-starts-phase-ii-trialsdrl-17822-molecule_582158.html

http://profit.ndtv.com/news/show/dr-reddy-s-starts-phase-ii-trials-of-drl-17822-molecule-175816

http://news.indiamart.com/story/dr-reddys-laboratories-starts-phase-ii-trials-drl-17822-molecule-europe-146110.html