BTI-320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. BTI-320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion, reducing the amount of available glucose absorbed through the intestine. We believe BTI-320 is a safe and effective drug compound for people with pre-diabetes and diabetes in their daily management of blood glucose levels, fulfilling an unmet medical need. We believe this compound may provide individuals with a means by which to slow the onset of Type 2 diabetes and/or the onset of diabetes complications such as heart disease, stroke, kidney damage, retinopathy and Diabetic Foot. BTI-320 will require FDA approval for marketing as a drug and will be subject to extensive regulation by governmental authorities in the United States and other countries.
Status of Development of BTI-320
On June 22, 2012, the Company announced that it has completed enrollment in a Phase II clinical trial to evaluate the safety and efficacy of BTI-320 when added to oral agents or insulin in patients with Type 2 diabetes at Dartmouth-Hitchcock Medical Center in Lebanon, NH. BTI-320 is a non-systemic chewable tablet designed to reduce post-meal elevation of blood glucose. On April 10, 2012, the Company announced that interim data analysis of the Phase II clinical trial showed that there were no serious adverse events from BTI-320. 24 patients with Type 2 diabetes were included in the open label, dose escalation crossover trial. The patients were adults age 18-75 with Type 2 diabetes, on insulin or oral agents, with a body mass index of 25-45 kg/m2 and with an A1C of less than or equal to 9%. The A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past three months. The Company expects to report Phase II final results by the second quarter of 2013.