Boston Therapeutics, Inc. (or “the Company”) develops products to address the diabetes and inflammatory disease markets using complex carbohydrate chemistry (CCC) technology. The Company’s portfolio includes two development-stage pharmaceutical candidates as well as a marketed over-the-counter (OTC) dietary supplement. The lead pharmaceutical candidate, BTI320 (formerly PAZ320), is a Phase II/III non-systemic, non-toxic, carbohydrate-based chewable tablet being evaluated as a therapy for Type 2 diabetes in patients currently taking metformin. The compound inhibits enzymes that release glucose from complex carbohydrates in foods during digestion—reducing the amount of glucose released from digested complex carbohydrates.
Boston Therapeutics’ second pipeline candidate is Ipoxyn™ (and a veterinary analog of Ipoxyn™, called OxyFex™), which is a carbohydrate-based intravenous solution in development to treat hypoxic conditions caused by a lack of oxygen to living tissue, such as lower-limb ischemia stemming from severe diabetes. The Ipoxyn™ molecule, which is 5,000 times smaller than a red blood cell (RBC), works by picking up oxygen in the lungs and offloading it to tissue that has been oxygen-deprived. The Company is positioned to benefit from two simultaneous paths to market—OTC and pharmaceutical drug development.
Key Points About Boston Therapeutics’ Business
In a Phase IIa trial, BTI320 showed a 40% reduction in elevation of post-meal blood sugar with no serious adverse events. Enrollment in Phase IIb is underway, with the Company preparing for an IND filing with the FDA for a Phase III study.
Over 382 million people are living with diabetes, which is projected to be 592 million by 2035. By 2018, the global market for diabetes drugs is forecast to be $58 billion, up from ~$35 billion today.
The Company’s OTC product, SugarDown®, is a chewable tablet designed to support healthy blood sugar levels. It is available and generating revenue in the U.S. and in two Asian markets.
Boston Therapeutics expects to file a registration for OxyFex™ and could begin marketing the compound for veterinary applications within 12 months of funding in a variety of locations worldwide.
The Company holds intellectual property to protect its carbohydrate drug technology. Management is experienced in regulatory and clinical development, having made multiple submissions and approvals to the FDA. Founder Dr. David Platt is a world-renowned scientist and has developed or co-developed core technologies for three public companies.
In 2013, the Company raised $5.6 million in support of clinical development. At December 31, 2013, its cash position was roughly $3.4 million and current liabilities were approximately $340,000.
For more detailed key points, see our summary of Boston Therapeutics here.
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