Boston Therapeutics, Inc., along with its Hong Kong-based strategic partner Advance Pharmaceutical Company, announced today the signing of agreement with pharmaceutical manufacturing company, Patheon Inc. This agreement is to manufacture pharmaceutical-grade tablets of BTI-320, the Company’s lead product candidate designed to reduce post-meal elevation of blood glucose.
This agreement was finalized in anticipation of Boston Therapeutics’ predicted IND filing in late 2014, as well as the Company’s planned international Phase III trial for BTI-320, which could initiate in 2015. One batch of BTI-320 is expected to be manufactured within a six-month timeframe, during which all methods development, analytical, stability, and other necessary tests will be performed under the IND requirements.
Patheon Inc. is a pharmaceutical company (incorporated in Canada and with corporate offices in Durham, North Carolina), which provides contract development and manufacturing services of prescription and over-the-counter (OTC) pharmaceutical products for approximately 300 pharmaceutical and biotechnology companies. Its global manufacturing network includes approximately 6,000 employees providing services at 12 commercial contract manufacturing facilities, and nine development centers across North America and Europe.
About BTI320 for Diabetes
The BTI320 compound—which is currently in Phase II trials—works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose. This reduces the amount of glucose available for absorption into the bloodstream. The majority of anti-diabetes drugs on the market today—hypoglycemic drugs—force blood sugar levels down systemically by targeting organs, such as the pancreas and other cells within the body. This can increase the risk of side effects, as has been shown in recent Food and Drug Administration (FDA) findings. In contrast, BTI320 offers a preemptive approach to blood sugar management by targeting enzymes in the mouth and small intestine to reduce the uptake of glucose during the digestion of carbohydrate foods—which may provide for an improved safety profile.
The active ingredient in BTI320 is mannan. Mannans are a group of plant-derived complex carbohydrates, or polysaccharides, which consist mainly of polymers of the sugar mannose. Some of the plants from which mannans are derived include guar, locust bean, fenugreek, barley, and konjac. Published studies on mannans have shown that they possess significant biological activity—ranging from inhibiting cholesterol absorption, promoting wound healing, and inhibiting tumor growth. Studies have also shown that consuming mannan before a meal can reduce the rise in blood glucose subsequent to that meal. Therefore, supplementation with mannan may be beneficial in the management of diabetes by supporting healthy blood sugar levels.
The Company entered into a clinical trial at Dartmouth Medical Center in Lebanon, New Hampshire, for BTI320 to measure post-prandial elevation of blood glucose. The goal was to leverage data from this study in the marketing of BTI320. This Phase IIa trial, with results recently published in the peer-reviewed journal Endocrine Practice, showed that BTI320 was well tolerated in patients taking various anti-diabetic agents, including metformin.
BTI320’s safety profile has reduced risk due to its Generally Recognized as Safe (GRAS) classification, and as well, has a 505(b)(2) accelerated development pathway for FDA approval. This route permits companies to obtain FDA approval of New Drug Applications (NDAs) by relying, in part, on the FDA’s findings for a previously approved drug. The benefits are many as this method may provide for a more expeditious way of achieving approval for product candidates by employing third-party data in support of a company’s own clinical studies.
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