Headline results from first phase III study of Balaglitazone announced

Jan 4 2010

Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) and Rheoscience, a subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III study for their investigational agent, Balaglitazone. The study (Study 307) was a phase III, randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine the efficacy and safety of balaglitazone. The study showed that the trial met its primary endpoint of reduction in HbA1c.

“These results offer the opportunity for a constructive series of dialogues with both potential partners as well as regulatory agencies. We look forward to working with Rheoscience to define the path forward for Balaglitazone”

The study explored the impact of adding placebo, Balaglitazone 10mg, Balaglitazone 20mg or Pioglitazone 45mg to a background treatment regimen of stable insulin therapy for a period of 26 weeks. The primary endpoint was HbA1c reduction, while several secondary endpoints including fasting plasma glucose, oedema, weight gain, and body composition were considered.

In all, 409 patients were randomized in roughly equal proportions across the four arms of the study. All three active arms (Balaglitazone 10mg, 20mg and Pioglitazone 45mg) showed similar levels of efficacy with respect to both HbA1c and fasting plasma glucose.

All three active arms showed good tolerability and adverse event profile, with Balaglitazone 10mg demonstrating less water retention, less fat accumulation, lower weight/BMI gain and less bone loss when compared to the Pioglitazone arm. Adverse events were numerically similar across the three active arms, with adverse events of special interest (bone fracture, hematuria, heart failure, cardiac ischemia, oedema, weight gain) being numerically under-represented in the Balaglitazone 10mg group compared to Pioglitazone 45mg.

“These results offer the opportunity for a constructive series of dialogues with both potential partners as well as regulatory agencies. We look forward to working with Rheoscience to define the path forward for Balaglitazone,” said GV Prasad, Vice Chairman & CEO, Dr. Reddy’s.

Commenting on these results, Dr. Claus Christiansen, Chairman- Nordic Bioscience said, “We are encouraged by these results, which demonstrate the safety and efficacy of Balaglitazone, especially of the 10mg dose in relation to Pioglitazone. We intend to further seek guidance from regulatory agencies on additional studies needed to register Balaglitazone.”

Data from the study will be submitted for presentation at upcoming international scientific meetings and to peer-reviewed journals.