Boston's IND For Type 2 Diabetes Drug Accepted By FDA

Boston Therapeutics announced that its Investigational New Drug Application (IND) for BTI-320 as treatment for Type 2 diabetes and to help manage weight has been accepted for review by the U.S. Food and Drug Administration (FDA).

BTI-320 is a non-systemic, chewable, complex carbohydrate-based compound that works to reduce post-meal elevation of blood sugar. The drug is a polysaccharide that needs to be taken before meals to maximize its mechanism of action in the gastrointestinal tract. There the drug blocks carbohydrate-hydrolyzing enzymes from breaking down complex carbohydrates into simple sugars. BTI-320’s mechanism of action lowers the availability of glucose for absorption in the bloodstream.

Earlier this year, the company filed a patent application for BTI-320 in regards to the drug’s molecular mechanism of action recently discovered in a pre-clinical trial. The application covers the novel diabetes treatment methods based on BTI-320’s relationship to a-amylase, an enzyme crucial in the breakdown of starch in the body.

Dr. David Platt, CEO of Boston Therapeutics, said, “Earlier this year, we completed a U.S.-based Phase 2b study of BTI-320 in patients with Type 2 diabetes and reported positive topline results. The results of our studies to date provided us with information on different patient populations and doses that have allowed us to design a protocol for this trial using mean change in HbA1c as the primary endpoint, which is the standard for measuring efficacy in currently available diabetes therapies.”

The company said it is designing the clinical study for BTI-320 as a placebo-controlled, randomized, double-blind study with two treatment arms. The trial will investigate the effect of BTI-320 plus metformin, Dipeptidyl peptidase-4 inhibitors (DPP-4), sulfonylureas and/or long-acting insulin analog on glucose control in patients with T2D. Primary endpoint of the study will be mean change in HbA1c levels from baseline at 24 weeks.

Boston Therapeutics said the trial will enroll up to 360 subjects for the study, which it will conduct in several international centers in the U.S., EU, Asia, and Australia.