Dr. Reddy’s, Rheoscience Report Phase III Trial Results For Balaglitazone

Dr. Reddy’s Laboratories and Rheoscience, a subsidiary of Nordic Bioscience, have reported the headline results from the first phase III study for their investigational agent, Balaglitazone.

Reportedly, the study (Study 307) was a phase III, randomised, 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.

The company said that 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 the study, over 409 patients were randomised 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.

GV Prasad, vice chairman and CEO of Dr. Reddy’s, said: “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.”

Claus Christiansen, chairman of 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.”