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 www.bostonti.com
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