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.

drreddys/