Evaluation of the effect of BTI320 in addition to current treatment with antidiabetic agents and/or long-acting insulin analogs on glycemic control in patients with type 2 diabetes
LAWRENCE, MA -- (Marketwired) -- 04/26/17 -- Boston Therapeutics, Inc. (OTCQB: BTHE) and its Asian partner Advance Pharmaceutical Company Limited, Hong Kong, announced today the fully financed new trial plans to support the safety and efficacy of BTI320, starting with a randomized, placebo-controlled, double-blinded, multi-center, international study on type 2 diabetic (T2D) patients. The study will initiate as soon as drug supply is processed and will ultimately include 300 T2D patients currently on anti-diabetic regimen. Recruitment will initiate at the Joslin Diabetes Center, Boston, MA, and will be joined by its former trial center form the Chinese University of Hong Kong (CUHK) which has also been confirmed. The plans anticipate up to 10 additional institutions from the US and greater China.
The post-prandial hyper-glycemia (blood glucose rapid increase) still remains a problem in the management of type 2 diabetes. Increase in these fluctuations exacerbates oxidative stress, a well-known problem and precursor to many metabolic disease states. The biggest challenge in maintaining healthy blood sugar level is the management of post-prandial (after meal) sugar spikes. Conventional capillary glucose measurements may be insufficient to capture the glucose variabilities experienced by diabetic patients. BTI320, an investigative material from Boston Therapeutics, has been in development in the past several years with operational partners in Asia. Presently, it has advanced to present a very important role in reducing post-prandial hyperglycemia. With its non-systemic effect, Boston Therapeutics goal to illustrate that it can enhance the management role either alone or alongside the many hypoglycemic drugs that work directly in the blood stream. Secondarily, Boston Therapeutics seeks to show that BTI320 may show an early on, safe and convenient alternative to diet and exercise regimens. To compliment the benefits of advanced technology in self-management technique, Boston Therapeutics is also working toward better healthcare management with consideration for precision medicine control (moderation of systemic drugs) to complement existing data assembly and to provide a more complete view of safety and efficacy for the management and control of diabetes and related metabolic diseases with a better outcome. One outcome measure will be HbA1c reduction, with special focus for intervention including personalized diets to control postprandial glucose excursion (PPGE) and glycemic variability, thereby modifying its subsequent metabolic consequences.
Type 2 diabetes is a multi-factorial disease and identification of various pathological mechanisms that contribute to the progression of the disease is ongoing. Development of new drugs will provide new treatment modalities to help people with diabetes in improving their diabetes management. Where HbA1c is the 'gold standard' commonly used to monitor long term glycemic control and guide medication adjustments, it can only reflect the change in fasting and postprandial glucose (PPG) levels for the past 3-months. Targeting both post-meal plasma glucose and fasting plasma glucose is an important strategy for achieving optimal glycemic control and reducing post-meal plasma glucose excursions is as important for achieving the goal of lowering HbA1c. A real-time glucose monitoring system would therefore precisely monitor the efficacy in PPG reduction and explore the safety in hypoglycemic event aversion of anti-diabetic drugs. Continuous glucose monitor (CGM) helps T2DM patients identify changing glucose levels in real-time and help improve control on their conditions.
The positive effect of BTI320 on postprandial hyperglycemia in high risk pre-diabetic Chinese population was demonstrated in a proof of concept trial (Protocol Code: SG01) completed at the CUHK/Prince of Wales Hospital (PWH) last year (June 2016). These positive Ph 2 data supports the safety and efficacy of BTI320 and clinical findings have been posted on Clinicaltrials.gov (NCT02358668) as of Jan 2017. Both the clinical study report and manuscript for the study are currently under preparation. The abstract Hyperglycemia in High-Risk Chinese Subjects with Prediabetes, has been selected for a poster presentation at the American Diabetes Association's 77th Scientific Sessions, June 9-13, 2017 in San Diego, California. It will also be printed in the Scientific Sessions Abstract Book, the June 2017 supplement to the journal Diabetes.
The Company also developed and markets SugarDown®, a sugar blocker dietary food supplement designed to support glycemic health. More information is available at www.bostonti.com . SugarDown® in its present formulation is a natural sugar blocker dietary supplement product made entirely from a non-digestible sugar molecule that can help people maintain healthier weight levels and is the first chewable tablet of its kind. In a previous study, SugarDown® demonstrated significant reduction of glucose and insulin Area Under the Curve (AUC) when taken with Jasmine rice, a food with a glycemic index of about 90 compared to glucose, which is 100. Sugary soft drinks that also have high glycemic index, include sucrose and maltose which is also found in beer. More information can be found on www.sugardown.com
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Lawrence MA, (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 HbA1C.
Forward Looking Statement
This press release includes forward-looking statements. These statements may be identified by words such as "feel," "believes," expects," "estimates," "projects," "intends," "should," "is to be," or the negative of such terms, or other comparable terminology. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein. Factors that could cause actual results to differ materially include, but are not limited to: our limited operations and need to expand in the near future; risks associated with obtaining regulatory approval of our products; the ability to protect our intellectual property; the potential lack of market acceptance of our products; potential competition; our inability to retain key members of our management team; our inability to raise additional capital to fund our operations and business plan; our ability to continue as a going concern; our liquidity and other risks and uncertainties and other factors discussed from time to time in our filings with the Securities and Exchange Commission ("SEC"), including our annual report on Form 10-K filed with the SEC. Boston Therapeutics expressly disclaims any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
Source: Boston Therapeutics