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RedHill Biopharma Ltd’s irritable bowel syndrome treatment study meets main goal

The company said it intends to start a late-stage study for the drug and plans to meet with the U.S. FDA by early next year to discuss the path toward potential marketing approval

Irritable Bower Syndrome
It is estimated that around 30 mln Americans suffer from IBS, and more than 50% are diarrhea-predominant.

RedHill Biopharma Ltd (NASDAQ:RDHL) said on Tuesday that its mid-stage trial of a treatment for diarrhea-predominant irritable bowel syndrome (IBS-D) met its primary endpoint in a Phase II trial.

The Israel-based company said in a statement that the placebo-controlled trial of Bekinda involved 126 subjects over 18 years old at 16 clinical sites in the U.S.

Plans for late-stage study

"We are greatly encouraged by the top-line results from the Phase II study which demonstrated that BEKINDA(R) 12 mg could be an effective treatment for patients suffering from IBS-D, and we look forward to discussing the path towards potential marketing approval in the U.S. with the FDA.," RedHill's medical director Terry Plasse said.

The company said it intends to start a late-stage study for the drug and plans to meet with the U.S. Food and Drug Administration by early 2018 to discuss the path toward potential marketing approval.

Bekinda also being tested for two other ailments

It is estimated that around 30 mln Americans suffer from IBS, and more than 50% are diarrhea-predominant.

The market for treatments rose about 550% between 2013 and 2016 and generated sales of US$473mln in 2016.

RedHill is also testing Bekinda for the treatment of acute gastroenteritis and gastritis.

In premarket trade, its shares dipped 5.37% at US$10.23.

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