Boston Therapeutics, Inc. is focused on developing products that address the diabetes and inflammatory disease markets, employing novel complex carbohydrate chemistry (CCC) technology.The Company’s portfolio includes two development-stage candidates—BTI-320 and Ipoxyn (and veterinary analog OxyFex)—and a marketed over-the-counter (OTC) dietary supplement called SugarDown®. The Company is positioned to benefit from two simultaneous paths to market—OTC and pharmaceutical drug development.
BTI-320 is a non-systemic tablet for the post-meal reduction of the elevation of blood glucose. The compound is designed to be taken before meals to inhibit the carbohydrate-hydrolyzing enzymes that release glucose from carbohydrates during digestion. BTI-320 has demonstrated a favorable safety profile with minimal side effects, in large part because it is a non-systemic method for treating diabetes. The Company is preparing documents for an IND submission with the FDA for a Phase III study. BTI-320 addresses an unmet medical need for people to manage their blood sugar, especially in those who are pre-diabetic and for people with Type 2 diabetes. Lower blood glucose is believed to slow the onset and progression of diabetes and its complications.
The compound’s API holds Generally Recognized as Safe (GRAS) classification. The Company’s strategy of combining proven compounds with novel delivery methods and pharmaceutical compositions seeks to reduce development time and costs and lower regulatory risks, while delivering valuable products in areas of unmet need to the marketplace.
A Phase IIa trial conducted at Dartmouth Medical Center in Lebanon, New Hampshire, showed that BTI-320 was well tolerated in patients taking various anti-diabetic agents, including metformin. Phase IIb is ongoing and has completed patient enrollment. Trial results are expected in late 2014.
Boston Therapeutics’ marketed product, SugarDown®, is an OTC, non-systemic, chewable dietary supplement taken prior to meals in order to reduce post-meal elevation in glucose. The product works in the gastrointestinal tract to reduce the spikes in blood sugar associated with eating high carbohydrate foods.
Also in development is Ipoxyn, a glycoprotein-based injectable therapeutic agent that may prove successful in reversing an inadequate supply of oxygen and support various metabolic functions in the body in a manner and with effects similar to those resulting from the infusion of RBCs—without the limitations of compatibility, availability, short shelf life, volume, and logistical challenges commonly associated with whole blood transfusions. The initial indication for Ipoxyn could be lower-limb ischemia associated with diabetes.
Ipoxyn is being targeted to both the human and animal market—where tissues and organ systems are deprived of oxygen and are in need of metabolic support.
Boston Therapeutics’ management is highly experienced, with its CEO, David Platt, Ph.D., a pioneer in designing therapeutic drugs made from carbohydrates for the past two decades. He is also the inventor or co-inventor on a number of patents and been significantly involved in the approval process for several drugs.
The Company is the third start-up founded by Dr. Platt—the first two were International Gene Group, whose core technology GCS-100 was acquired by Prospect Therapeutics, and is now known as LaJolla Pharmaceuticals, and Pro-Pharmaceuticals, which is now Galectin Therapeutics. Core technologies of both of these companies were either developed or co-developed by Dr. Platt.
Boston Therapeutics’ product candidates are well-differentiated formulations that address significant unmet medical needs. The Company is working to secure a robust intellectual property portfolio composed of patents, patent applications, and trademarks.
The technology and products are currently protected by two patent applications filed under the international Patent Cooperation Treaty (PCT) and their related national-stage applications, one provisional patent application in the U.S., and several trademarks.
Boston Therapeutics’ patent portfolio covers three main areas: (1) mannans; (2) hemoglobin composition and methods of use; and (3) taste masking in chewable tablets.
At June 30, 2014, the Company held cash and cash equivalents of over $1.5 million. In August 2014, Boston Therapeutics filed a preliminary Form S-1 with the SEC for the raise of up to $10 million.