Boston Therapeutics, Inc. (BTHE-OTCQB), a developer of complex carbohydrate therapeutics to treat diabetes, announced that it signed a clinical trial agreement with the prestigious Joslin Diabetes Center in Boston to be the lead clinic for the Company’s Phase III study of its candidate BTI-320.
BTI-320, a new generation of alpha glucosidase inhibitor, is a non-systemic chewable tablet designed to reduce post-meal elevation of blood glucose. BTI-320 is designed to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose and release it into the bloodstream.
The Joslin Diabetes Center is expected to enroll 30 patients, and will serve as the lead clinic for the Phase III study, which is scheduled to commence in 2015. The Phase III study plans to assess a total of 360 patients, divided in 10 sites in four countries, including the U.S., and is expected to run for approximately 24 weeks.
The trial's primary endpoints are the evaluation of the effect of BTI-320 on HbA1c (a form of hemoglobin measured to identify the average plasma glucose concentration over prolonged periods of time), after-meal blood glucose, and fasting plasma glucose. BTI-320 is to be evaluated in conjunction with current treatments in patients with Type 2 diabetes.
Previously, the Company reported positive results from its Phase II clinical trial evaluating the safety and efficacy of BTI-320. Forty-five percent of patients responded with a 40% reduction of post-meal glucose in the blood compared to baseline in a dose-dependent manner. There were no serious adverse events.
About Joslin Diabetes Center
Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes research and clinical care organization. Joslin is dedicated to ensuring that people with diabetes live long, healthy lives and offers real hope and progress toward diabetes prevention and a cure. Joslin is an independent, nonprofit institution affiliated with Harvard Medical School.
About Boston Therapeutics, Inc.
Boston Therapeutics is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including BTI-320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug designed initially to treat lower limb ischemia associated with diabetes. The company also produces and sells SUGARDOWN®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose.