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FDA OKs Trials for Drug to Combat Diarrhea

By Dan Flynn and Suzanna Schreck

Saying it is hard to overstate the need for such a medicine, the Institute for OneWorld Health (iOWH) this week announced that the U.S. Food and Drug Administration has granted approval to begin phase 1 trials for a drug to treat secretory diarrhea.
Diarrheal diseases--such as cholera--kill nearly 5,000 children in developing countries every day, more than AIDS, tuberculosis and malaria combined, the IOWH said in a news release.
Standard treatment for cholera and other infectious diarrheas is now oral rehydration therapy. The new drug, funded by the Bill & Melinda Gates Foundation, reduces fluid loss and is designed to be used in conjunction with oral rehydration therapy to combat dehydration.
"This is the first submission of an Investigational New Drug application for a completely new chemical entity by a non-profit of this size to receive such rapid FDA clearance, and it could be the first synthetic drug of its kind for diarrheal diseases," the iOWH said in the statement.
The new drug, known as iOWH032, acts by targeting the cells that line the intestines. This prevents the bacteria, such as cholera, from being able to force the body to secrete massive amounts of fluid.
Dr. Richard Chin, iOWH CEO, said the San Francisco-based institute hopes to begin phase 1 human trials in April.

Full post as published by Food Safety News on March 04, 2011 (boomark / email).