Boston Therapeutics completes enrollment for BTI-320 Clinical Trial

The clinical trial had 60 pre-diabetic patients.

This key developmental trial, being conducted in Hong Kong and the associated endpoints are pivotal for concluding the BTI-320 registration in mainland China.

This clinical trial is supplemental to an on-going separate clinical trial, being conducted in mainland China. It is expected to be completed by year end and the overall dossier for approval is targeted to be submitted in January 2016 for pending country wide approval in the first half of 2016. BTI-320 is planned to address and benefit a population of 495,000,000 pre-diabetic people in China (JAMA. 2013 Sep 4;310(9):948-59) and 50% of the entire population in the USA, who are pre-diabetic and diabetic (JAMA. 2015;314(10):1021-1029) and could make a significant contribution to controlling healthcare costs.

Enrollment in the CUHK first trial was completed ahead of schedule and is expected to confirm the assessment of prevention biomarker parameters associated with postprandial glucose (PPG) spikes measured with Continuous Glucose Monitoring (CGM) device, Fructose accumulation (Fructosamine blood testing) and HbA1c (Glycated Hemoglobin).

PPG maximum amplitude peaking and Fructosamines appears to be a major detriment and predicament to lowering HbA1c and forestalling the onset and the advancement of Type 2 Diabetes without the hypoglycemic threat possible with many of the compounds presently associated with diabetes treatment.

The Chinese FDA process is a major focus of APC’s alliance partnership in Asia, where they are piloting clinical marketing education programs, specifically in Korea, Hong Kong, Singapore, and most recently Japan. APC has under license from Boston Therapeutics Inc. 15 countries in South East Asia.

David Platt, Ph.D., CEO of Boston Therapeutics, said, "BTI-320 is the only drug candidate in development to safely block Glucose, Fructose and other sugars simultaneously with a single molecular structure.

With over 150 patients treated to date, there are no Serious Adverse Effects (SAE) observed. We are fortunate to have APC as a financial partner to conduct and fund these and other studies and look forward to commercializing BTI-320 where we may help many people to manage this world health mandate to manage blood sugar."

Boston Therapeutics developed BTI-320 and markets it through APC in Asia. BTI-320 is a non-systemic compound (working only in the intestine not in blood), designed to block the increase of post-meal elevation of blood Glucose, Fructose and other key Sugars.

BTI-320 is 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 Fructose and other sugars for absorption into the bloodstream.

Dr. Juliana CN Chan, PRCP is the lead principal investigator and the lead clinical site is the Department of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital