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news.RedHill Biopharma has started a US-based phase 2 clinical trial assessing Bekinda (ondansetron) to treat patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
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The double-blind, two-arm parallel group study will randomize 120 patients to receive 12 mg of Bekinda or placebo once daily for eight weeks.
The primary endpoint is the proportion of patients with response in stool consistency versus baseline.
Secondary endpoints include the proportion of patients in each treatment group who are pain responders and who are responders to the combined endpoints of stool consistency and pain.
RedHill Biopharma COO Gilead Raday said: "This study follows publications demonstrating that ondansetron, the active ingredient in Bekinda, may be an effective and safe treatment for IBS-D.
"We also continue to advance the Phase III GUARD study of Bekinda for acute gastroenteritis and gastritis, currently ongoing in the U.S., with top-line results expected during the second half of this year."
Bekinda is an extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications.
RedHill is undertaking clinical studies with two dose strengths of Bekinda, a 24 mg dose and a 12 mg dose. 5-HT3 antagonists like ondansetron, the active pharmaceutical ingredient in Bekinda, have demonstrated to slow intestinal transit time in humans.
Alosetron, a 5-HT3 antagonist of the similar class of drugs as ondansetron, the active ingredient in Bekinda, has been approved to treat women with serious chronic IBS-D. It is under a restricted prescribing program due to potential severe side effects.