Dr Reddy’s diabetes drug impresses in Phase III
World News | January 04, 2010
Dr Reddy’s Laboratories’ hopes of being the first Indian drugmaker to get an innovative treatment for diabetes to the market have been boosted by the reporting of positive late-stage data on balaglitazone.
The company and partner Rheoscience, a Denmark-based subsidiary of Nordic Bioscience, have announced headline results from the first Phase III study of balaglitazone. The 409-patient trial showed that 10mg and 20mg doses of the drug had similar efficacy to 45mg of Takeda’s Actos (pioglitazone) in reducing glycosylated haemoglobin (HbA1c) and fasting plasma glucose levels.
Furthermore, the 10mg dose of balaglitazone demonstrated less water retention, fat accumulation, weight gain and bone loss than pioglitazone. Dr Reddy’s also noted that adverse events of special interest (bone fracture, haematuria, heart failure, cardiac ischemia, oedema and weight gain) were numerically under-represented in the 10mg group compared to Actos.
Dr Reddy’s chief executive GV Prasad said the results “offer the opportunity for a constructive series of dialogues with both potential partners, as well as regulatory agencies’. He added that “we look forward to working with Rheoscience to define the path forward for balaglitazone”.
The compound, a novel partial agonist of PPAR-gamma, was out-licensed in 1997 to Novo Nordisk but the Danish firm returned the rights to Dr Reddy’s in 2004, when Rheoscience came on-board.
Click here to order a reprint of this news story.