OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

The Institute for OneWorld Health (iOWH) announced a major milestone in the fight against cholera. The Food and Drug Administration (FDA) granted iOWH permission to begin phase 1 trials for iOWH032, a drug to treat secretory diarrhea. 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.

“As vital as ORT has been to saving lives, we need to do more to get at the ways diseases, such as cholera, kill. We hope to start phase 1 human trials by April 2011.”

The standard treatment for cholera and other infectious diarrheas characterized by massive loss of fluid is oral rehydration therapy (ORT) to manage life-threatening dehydration. While ORT is highly effective at saving lives, it does nothing to stem the fluid loss, and it must be continued for the duration of the illness. As a result, many do not complete the therapy before the disease has been eliminated and are at increased risk of morbidity and mortality. This new drug, whose development was funded by the Bill & Melinda Gates Foundation, reduces fluid loss and is designed to be used in conjunction with ORT. This treatment would provide faster relief of diarrhea symptoms and encourage wider adoption of ORT resulting in reduction of mortality rate and improvement of quality of life.

"It is hard to overstate the need for this kind of medicine. Diarrheal diseases - such as cholera - kill more children in developing countries than AIDS, tuberculosis and malaria combined. Nearly five thousand children die every day because of these diseases. For survivors - and children often face repeated bouts with cholera and other diarrheal diseases often in their lives - the threat they pose is ongoing. Of all childhood infectious diseases, these have the greatest effect on growth, by reducing appetite, altering feeding patterns, and decreasing absorption of nutrients. The number of episodes in the first two years of life also affects fitness, cognitive function, and school performance," said Richard Chin, MD and CEO of iOWH, "As vital as ORT has been to saving lives, we need to do more to get at the ways diseases, such as cholera, kill. We hope to start phase 1 human trials by April 2011."

The new class of drugs represented by 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. A full description of how this occurs can be found here: http://bit.ly/gfWIAQ. For the past decade iOWH has committed itself to being an agent of change in the area of diarrheal diseases. More information on their programs can be found here: http://bit.ly/ho4LVF and here: http://bit.ly/dXK24T.