RedHill Biopharma Ltd said on Tuesday its drug to treat diarrhea-predominant irritable bowel syndrome met the main goal in a mid-stage study, but the positive data failed to impress investors, sending its U.S.-listed shares lower.
The company said the drug, Bekinda, improved stool consistency in patients when compared with a placebo. The drug, however, did not show statistical significance in improving abdominal pain and overall response in patients – secondary goals in the study.
U.S.-listed shares of the Tel Aviv-based company are down about 11.2 percent at $9.60 in late morning trade.
“The study was not designed or meant to show significance in the secondary endpoints … the results are actually good according to the small sample size,” RedHill’s Chief Executive Dror Ben-Asher told Reuters.
The trial was testing a 12-mg dose – a once-daily oral pill formulation of a 5-HT3 receptor antagonist called ondansetron – in 126 patients over 18 years of age.
Receptor antagonists such as 5-HT3 are a class of drugs known to slow intestinal movement in patients.
The U.S Food and Drug Administration has already approved a different kind of 5-HT3 antagonist called Lotronex in the United States to treat women with IBS-D.
Other drugs to treat IBS-D in both men and women include Valeant Pharmaceuticals International Inc’s Xifaxan and Allergan Plc’s Viberzi.
RedHill told Reuters it expects to start a late-stage trial on Bekinda by late 2018.
Irritable bowel syndrome is a chronic condition that affects up to 30 million people in the United States, out of which over 50 percent cases belong to IBS-D, the company said.
The disease has two other forms: constipation (IBS-C) and mixed (IBS-M).
RedHill is also testing Bekinda to treat acute gastroenteritis and gastritis, an inflammation of the stomach and intestines that causes vomiting and diarrhea.
In June, RedHill reported positive results from a late-stage trial testing the drug in patients with gastroenteritis
[“Source-timesofindia”]
