The phase-I clinical trials of DRF 10945, a drug candidate discovered by Dr Reddy’s Laboratories and targeted for the treatment of blood lipid dysfunction (dyslipidemia), has commenced in Canada on February 26, 2004. The Clinical Trial Application for DRF-10945, which represented the first new chemical entity (NCE) submission in Canada and overseas for the company, received no objection from the Therapeutic Product Directorate, Canada, for clinical investigation.
Dyslipidemia is a condition which results in abnormal levels of triglycerides and cholesterol in the blood and increases the risk of cardiovascular diseases.
"This is another significant and exciting milestone for Dr Reddy's NCE discovery and clinical development programme and attests to the commitment of the company in finding break-through medicines for unmet needs. DRF 10945 is a promising new oral drug candidate which by treating dyslipidemia will ultimately provide therapeutic benefits for treatment of cardiovascular disease, a rapidly growing menace worldwide," stated Dr Uday Saxena, chief scientific OFFICER, Dr Reddy’s Laboratories.
DRF 10945, a PPAR alpha agonist, represents a novel approach for reducing the risk for cardiovascular diseases (CVD) through effective management of dyslipidemia. It provides two beneficial effects - It lowers the levels of blood triglycerides as well as increases high-density cholesterol (HDL – good cholesterol). Recently, HDL has obtained heightened importance due to the possibility of its contribution in reversing cardiovascular disease in patients. Also, due to its protective role, HDL levels may be a better predictor of cardiovascular disease than LDL levels.
Novel medicines that can impact both triglycerides and HDL management will be important additions to the medical arsenal for managing cardiovascular diseases effectively. Besides DRF 10945, Dr Reddy's is developing a diversified platform of compounds with distinct mechanisms of action for the treatment of dislypidemia, diabetes and associated cardiovascular disorders. Another significant drug candidate in Dr Reddy's cardiovascular programme is RUS 3108. It has a multi-pronged and direct disease attacking approach and is currently undergoing regulatory toxicology studies.
Dr Reddy’s Laboratories conducts its drug discovery research activities in facilities at Hyderabad and Atlanta. The company currently has eight new molecules under various stages of clinical development. DRF 2593 (Balaglitazone), which was outlicensed to Novo Nordisk in March 1997, has completed Phase-II clinical trials. DRF-1042, which is the company’s first NCE in the anti-cancer area, is undergoing Phase II clinical trials and DRF 1644, the company’s second molecule in the anti-cancer area, is undergoing Phase-I clinical trials.