Pivotal Phase 3 Trial A Key Objective For Boston Therapeutics (BTHE) In 2014

Dec. 27, 2013 5:30 PM ETBTHE
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Boston Therapeutics is a pharmaceutical company using complex carbohydrate chemistry to advance its PAZ320 and IPOXYN drug candidates for the treatment of Type 2 diabetes. With 2013 under wraps, BTHE looks to have an exciting first half of the upcoming year.

In mid-2014, BTHE hopes to start a pivotal phase 3 study of PAZ320, a chewable tablet to be taken before meals to reduce post-meal elevation of blood glucose in Type 2 diabetics by blocking the action of carbohydrate-hydrolyzing enzymes.

The two-year study, to be conducted in the U.S., Europe, Hong Kong, Korea, and China, will evaluate the effects of PAZ320 on glucose and hemoglobin A1c (HbA1c) in approximately 300 Type 2 patients currently taking metformin.

Thus far, Acarbose is the only drug that has been developed for the non-systemic environment to prevent glucose formation, though it is accompanied by side effects and limited functionality. BTHE's goal is to develop a superior drug without the side effects.

An earlier phase 2 study of PAZ320 suggests that the company is on the right track in doing so. In the study, 21 patients treated with PAZ320 achieved a 40 percent reduction in post-meal blood glucose levels with no serious adverse events.

BTHE in November began enrolling patients in a phase 2b clinical study of PAZ320. A total of 24 patients currently being treated with metformin will receive PAZ320 in a double-blind, placebo-controlled study. The primary endpoint of the study is to evaluate the effect of PAZ320 compared to placebo to determine post-meal blood glucose levels after consumption of a test meal. The company plans to announce safety and glucose results during the first quarter of 2014.

For more information, visit bostonti.com

MissionIR provides investor relations services to publicly traded companies in exchange for compensation. This article may be part of our efforts to widen a client's exposure. To read our full disclaimer, visit http://disclaimer.missionir.com

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