This agreement was secured in anticipation of Boston Therapeutics’ anticipated IND filing in late 2014, as well as the company’s planned international Phase III trial for BTI-320 that is scheduled to be initiated in 2015.
One batch of BTI-320 will 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.
Boston Therapeutics CEO Dr David Platt noted that the manufacturing of pharma-grade BTI-320 tablets is essential to the preparation for our upcoming IND submission and our planned international Phase III trial.
"We are pleased to have secured the services of Patheon for this important project, a key step in our BTI-320 development efforts and our continued growth as a company," Dr Platt added.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose in Type 2 diabetic patients.
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.