Pivotal Phase 3 Trial a Key Objective for Boston Therapeutic
Pivotal Phase 3 Trial a Key Objective for Boston Therapeutics (BTHE) in 2014
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.
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