This morning, pharmaceutical company Boston Therapeutics, Inc. (BTHE-OTC) reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) filing for BTI-320, a new generation of alpha glucosidase inhibitor that is designed to reduce post-meal elevation of blood glucose. BTI-320 is expected to be taken before meals and works in the gastrointestinal tract to block the enzymes that break down and release carbohydrates into the bloodstream as glucose. With an approved IND, the company plans to start a major clinical study of BTI-320 in the first quarter 2015, as detailed in Boston Therapeutics' press release below.
MANCHESTER, NH -- (Marketwired) -- 12/10/14 -- Boston Therapeutics, Inc. (OTCQB: BTHE), a developer of complex carbohydrate therapeutics to treat diabetes and inflammatory diseases, today announced that the U.S. Food and Drug Administration ("FDA") has accepted the company's Investigational New Drug Application ("IND") for BTI-320 to treat Type 2 diabetes and weight management. The primary endpoints for the multicenter trial are the mean change in Hemoglobin A1c (or HbA1c) and weight loss. The Joslin Diabetes Center in Boston will be the lead clinic in the trial, which is planned to begin in the first quarter of 2015.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "Earlier this year, we completed a U.S.-based Phase IIb 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."
This study is being designed as a randomized, placebo-controlled, double-blind, international multicenter study with two treatment arms. It will evaluate the effect of BTI-320 in addition to current treatment with metformin, Dipeptidyl peptidase-4 inhibitors (DPP-4), sulfonylureas and/or long-acting insulin analog on glucose control in patients with Type 2 diabetes. The primary efficacy endpoint of the trial is the mean change in HbA1c levels from baseline at 24 weeks. The study will be conducted at number of international centers located in the U.S., Europe, Asia and Australia. Up to 360 subjects will be enrolled and treated in the study.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. BTI-320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) 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 developed and markets sugardown®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding our clinical development of BTI-320 are subject to factors beyond our control. We can provide no assurance we or our commercial partner will be able to generate market demand for sugardown®, and thus we may not be able to generate revenue from sugardown® sales.
Moreover, we have incurred operating losses since our inception, and our ability to successfully develop, market, manufacture, distribute and sell drugs or over-the-counter products may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC.
You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.