RedHill Bio's gastric drug succeeds in late-stage study

Reuters Health Information: RedHill Bio's gastric drug succeeds in late-stage study

RedHill Bio's gastric drug succeeds in late-stage study

Last Updated: 2017-06-14

By Reuters Staff

(Reuters) - Israel-based RedHill Biopharma Ltd said its experimental drug for the treatment of gastroenteritis met the main goal in a late-stage study.

The trial tested the efficacy and safety of the drug, bekinda, compared with a placebo, in 321 patients suffering from the condition.

Bekinda is a once-daily oral pill formulation of the existing anti-nausea drug ondansetron and is designed to provide relief from nausea and vomiting symptoms for a 24-hour period.

Data showed Bekinda can provide patients with 24 hours of relief and works regardless of the initial severity of gastroenteritis, the company said.

RedHill is still analyzing the dataset and plans to discuss the path to approval with the Food and Drug Administration, it added on Wednesday.

Gastroenteritis is very common in the United States, with about 179 million cases annually, and can be caused by many different infectious agents, typically viral infections, according to the Centers for Disease Control and Prevention.

Data from a mid-stage study testing bekinda in patients with diarrhea-predominant irritable bowel syndrome is expected in September.

U.S.-listed shares of Tel Aviv-based company rose about 5 percent at $9.92 in early trading on Wednesday.

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