Dr. Reddy's and Rheoscience Announce Headline Results from First Phase III Clinical Trial of Balaglitazone (DRF 2593)
HYDERABAD, India--(BUSINESS WIRE)--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.
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.
|Balaglitazone 10mg||Balaglitazone 20mg||Pioglitazone 45mg|
|HbA1c reduction against placebo||0.99 %||1.11 %||1.22 %|
|FPG reduction against placebo||1.42 mmol/L||1.80 mmol/L||1.35 mmol/L|
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.
Notes to the Editor
Balaglitazone is a novel partial agonist of PPAR-gamma, which elicits only 52% of the PPAR-gamma activation observed with both pio- and rosiglitazone. Pre-clinical studies have indicated that besides robust glucose lowering ability, balaglitazone results in lower body fluid accumulation, lower fat accumulation, less heart enlargement and no reduction of bone formation, indicating that Balaglitazone may be able to displace the balance between desired and side effects, and thus show a better safety profile than full agonists of PPAR-gamma.
About the Balaglitazone programme
The Balaglitizone Phase III clinical trial programme is designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies.
Type 2 diabetes is a major cause of morbidity and mortality in the industrialized world, with cardiovascular disease as the leading cause of death, accounting for almost 50% of all T2D deaths. Furthermore, the number of T2D patients is increasing rapidly, and the number of patients is expected to reach between 300 and 380 million by 2025, thereby placing an enormous economical burden on global healthcare.
This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.
About Dr. Reddy's
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company. We fulfill our purpose of providing affordable and innovative medicines through three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.
Rheoscience is a Danish biopharmaceutical company focused on the discovery and development of novel pharmaceutical products for the treatment of metabolic diseases such as diabetes and obesity. Rheoscience has unparalleled experience in developing drugs for metabolic disorders and draws on this to advance its own pipeline of innovative compounds and to underpin its successful, profitable contract research business.
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Posted: January 2010