Elcelyx Therapeutics has started enrolling type 2 diabetics for its dose finding, phase 2b clinical trial of its lead product NewMet. The company will be enrolling almost 240 patients in multiple centers across the United States. The company is expected to:
– Finish enrollment of diabetic patients by June.
– Record changes in fasting plasma glucose levels after administration of drug by the end of summer.
– Evaluation of long term results like benefits in terms of sugar control and weight reduction by the 4th quarter of 2013.
NewMet is the modified delayed release formulation of metformin that is similar to the traditional metformin with the difference that Elcelyx Therapeutics has modified the biodynamics of the drug after investigating that the primary site of action of metformin is not circulation but small bowel. The new and improved drug exerts its action mainly around the small bowel that reduces the drug concentration in the blood. This helps in the reduction of gastrointestinal complications and need of dose titration as indicated by phase 2a clinical trials.
In the trial, NewMet will be tested in a double blind dose finding study, utilizing the once- daily doses of 1,000, 800 and 600 milligrams against placebo. The researchers are looking to calculate the fasting glucose levels at the end of 4 week therapy. The secondary end-point evaluated at the end of 12 week period will evaluate the safety and tolerance of the drug in addition to fasting plasma glucose, hemoglobin A1C levels, and weight of study participants.
Ralph A. DeFronzo’s feedback on the development:
Ralph A. DeFronzo is a renowned physician, investigator and teacher who is known for his notable work in leading clinical trials on metformin that later led to the approval of drug for the management of hyperglycemia by U.S. Food and Drug Administration approval of metformin back in 1994.
DeFronzo is currently the Chief of the Diabetes Division at Audie L. Murphy Memorial Veterans Administration Hospital and the University of Texas Health Science Center and in San Antonio. The professor of Medicine, Ralph A. DeFronzo commented on the remarkable development of Elcelyx Therapeutics in these words:
“Elcelyx’s approach of reducing bioavailability of metformin is quite ingenious and turns on its head the incorrect belief that greater exposure to metformin is needed for superior therapeutic benefits. Results from previous NewMet trials indicate that by targeting the hormone-producing enteroendocrine cells in the lower gut, NewMet may have better tolerability with the preserved efficacy of metformin at a lower dose. This would make NewMet ideal for the millions of Type 2 diabetes patients who have difficulty tolerating metformin or are unable to take the medication due to contraindications. I am eager to see the results of the additional planned clinical studies of NewMet to further understand this attractive profile.”
The CEO and President of Elcelyx Therapeutics Alain Baron suggested that the aim of developing NewMet is to eliminate the gastrointestinal and renal side effects of generic metformin therapy. He added:
“The goal of this study is to demonstrate that NewMet has long-term glucose lowering benefits with a tolerability and safety profile that is superior to currently marketed metformin, the #1 diabetes product in the world. This would allow many more patients with Type 2 diabetes to enjoy the full benefit of metformin’s active ingredient.”
The primary action of the drug molecules on the lower gut makes it an ideal treatment of choice in patients who experience lactic acidosis with generic metformin. The company will be conducting future trials to ascertain safety and efficacy in patients with renal impairment that is expected to begin this summer.
Dr. DeFronzo and other investigators will be presenting the results of Phase 2a clinical trials of NewMet at 2013 American Diabetes Association Scientific Sessions in June.