SOURCE: Boston Therapeutics

Boston Therapeutics

June 08, 2015 06:18 ET

Boston Therapeutics Presents Findings of BTI-320, a Novel, Non-Systemic, Non-Hypoglycemic Drug Candidate as Therapy to Manage Blood Glucose at 75th Annual Meeting of the American Diabetes Association

MANCHESTER, NH--(Marketwired - Jun 8, 2015) - Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a developer of complex carbohydrate therapeutics to treat diabetes and inflammatory diseases, will present data on BTI-320, its novel, non-systemic, non-hypoglycemic drug candidate to manage blood glucose, as a poster presentation at the 75th Annual Meeting of the American Diabetes Association being held in Boston, June 5th to the 9th.

The poster, titled "Insight into the molecular mechanism of action of BTI-320, a non-systemic novel drug to control serum glucose levels," was written by a team of leading researchers led by Kevin H. Mayo, Ph.D., a professor in the Department of Biochemistry, Molecular Biology and Biophysics at the University of Minnesota, Minneapolis. Dr. Mayo and his team collaborated to investigate whether BTI-320 interacts directly with multiple carbohydrate hydrolyzing enzymes that break down carbohydrates like starch, sucrase or maltase into glucose, and can function to attenuate the rate of glucose release from digested complex carbohydrate foods. The researchers concluded that BTI-320 acts as a competitive inhibitor of enzymes, such as amylase, lactase, maltase, and sucrase among other key carbohydrate hydrolyzing enzymes. The findings were cross-checked and corroborated by two different scientific approaches: biochemical (enzymology) and biophysical (nuclear magnetic resonance). The poster's co-authors include David Platt, Ph.D., CEO of Boston Therapeutics, and Benjamin Rivnay, Ph.D., Chief Scientist.

BTI-320 is a non-systemic, non-hypoglycemic drug in a chewable tablet designed to be taken before meals in order to reduce post-meal rapid elevations of blood glucose in people who need to manage their blood sugar levels. BTI-320 is a proprietary drug to be taken before meals and works via the gastrointestinal tract to block the action of carbohydrate hydrolyzing enzymes. BTI-320 reduces blood glucose elevations from rapid excursions after a meal by reducing the glycemic load (the rush of absorbable glucose and fructose) from foods.

Dr. Mayo said, "Our results clearly indicate that components of BTI-320 bind to these hydrolyzing enzymes and competitively inhibit their activities. And although these are in vitro results, they strongly suggest that BTI-320 functions similarly in vivo, possibly in combination with other mechanisms of action on the physiologically level."

Dr. Platt said, "Our findings provide insight into how BTI-320 functions for glycemic control for patients with diabetes and metabolic diseases. It is a convenient, safe, non-toxic, non-hypoglycemic drug candidate that could be a 'game-changer' in the management of blood glucose levels. BTI-320 does not lower blood glucose levels; it keeps the glucose from spiking after a meal. We are pleased to be able to present this research at ADA 2015 and will continue to report additional findings as we obtain them and as the investigative drug material makes it way to approval."

"This new molecule targeting several digestive enzymes to slow the increase in post-meal blood glucose control will be a welcomed addition to the tools used by health care providers for all people affected by diabetes," said Larry Ellingson, former Chairman of the Board of the American Diabetes Association and chair of Boston Therapeutics Medical Advisory Board. "It is very well known that management of post meal glucose excursions is very important for the management of diabetes. Elevated serum glucose has been shown to cause several complications of diabetes, including those in the eyes, nerves and kidneys. Anything that helps the patient manage glucose control in people with diabetes will be a great addition to diabetes care."

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 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. 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 the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.

Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from our approved products. Plans regarding development, approval and marketing of any of our compounds, including BTI-320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. We have incurred operating losses since our inception, and our ability to successfully develop and market drugs 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, 2014, 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.

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