Boston Therapeutics, Inc. announced that its Hong Kong affiliate, Advance Pharmaceutical Company Ltd. (APC), is conducting a clinical trial at The Chinese University of Hong Kong (CUHK) to evaluate BTI-320 in subjects who are pre-diabetic.
The clinical trial has enrolled 30 of the planned 60 patients. Also, the interim analysis in the proof of concept trial is due to be reported shortly.
This key developmental trial and the associated endpoints are pivotal for concluding the BTI-320 registration in mainland China. The pivotal trial for product registration will enter the final phase for registration through testing this month July 2015. The clinical trial is planned 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 more than 350,000,000 million who are pre-diabetic and could make a significant contribution to controlling healthcare costs.
Enrollment in the CUHK trial is on track to conclude by October 2015 and is expected to confirm the assessment of prevention biomarker parameters associated with postprandial glucose (PPG) spikes. PPG maximum amplitude peaking appears to be a major detrimental aspect to lowering HbA1c and forestalling the onset and the advancement of type 2 diabetes without the hypoglycemic threat possible with many of the treatment 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 programmes, specifically in Korea, Hong Kong, Singapore, and most recently Japan.
David Platt, Ph.D., chief executive officer of Boston Therapeutics, said "We are pleased to enjoy this collaborative effort with APC and add to the beneficial effects of BTI-320 on people in China who are pre-diabetic, a population that is estimated to be more than three times the size of the known diabetes population. We are confident we will collect key information as a result of this study. We are fortunate to have APC as a financial partner to conduct and fund these and other studies and look forward to commercialising BTI-320 where we may help 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 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.
The single-centre, 16-week, randomized, double-blind, placebo-controlled, three-treatment arm pilot trial is designed to evaluate the tolerability, safety and efficacy of BTI-320 in high-risk Chinese subjects with pre-diabetes. The primary endpoint is change in serum fructosamine in subjects treated with low-dose BTI-320 and high-dose BTI-320 compared with placebo from baseline to week 4. The secondary endpoints include changes in Area Under the Curve_180 and HbA1c in subjects treated with low-dose BTI-320 and high-dose BTI-320 compared with placebo from baseline to week 4 and Week 16. A total of 60 subjects are expected to be recruited for the trial.
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.
Obesity is a major epidemic and excessive consumption of high-fructose corn syrup (HFCS) in beverages plays a role. The consumption of HFCS increased dramatically in the last several decades. Today, HFCS represents a significant portion of caloric sweeteners added to foods and beverages and is a caloric sweetener used in soft drinks. Sucrose is part glucose and part fructose. These are two 'sugars', one the body uses for energy and the other is made into fat if not utilised and converted into glucose. The digestion, absorption, and metabolism of fructose differs from the metabolism of glucose.
In addition, unlike glucose, fructose does not stimulate insulin secretion or enhance leptin production (the hormone that signals us to stop eating). Because insulin and leptin act as key afferent signals in the regulation of food intake and body weight, this suggests that fructose may contribute to increased energy intake and weight gain. Furthermore, calorically sweetened beverages may enhance caloric overconsumption. Thus, the increase in consumption of HFCS has a temporal relation to the epidemic of obesity, and the overconsumption of HFCS in calorically sweetened beverages may play a role in the epidemic of obesity.
BTI-320 is being administered as an oral chewable tablet containing either four grams of BTI-320 or matching placebo. All subjects are instructed to take two chewable tablets prior to meal ingestion. Low-dose BTI-320 consists of one active chewable tablet and one placebo chewable tablet; high-dose BTI-320 consists of two active chewable tablets.