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Irritable bowel syndrome study

15th April 2016

Posted By Paul Boughton


Irritable bowel syndrome (IBS) is a chronic multifactorial disorder characterised by recurrent abdominal pain or discomfort associated with altered bowel function. Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common subtype of IBS in the US Certain factors that may alter gastrointestinal function can contribute to IBS symptoms, including stress, prior gastroenteritis and changes in the gut microbiome. However, the etiology of IBS is not well-understood and the underlying cause of IBS in many cases remains unknown. IBS negatively impacts patients’ health-related quality of life and can affect patients physically, emotionally, socially and economically

IBS is one of the most common GI disorders; it is estimated that at least 30 million Americans suffer from IBS(5), of which over 50% are cases of IBS-D4. The US potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020.

Now RedHill Biopharma Ltd has initiated a randomised, double-blind, 2-arm parallel group Phase II clinical study in the US evaluating the safety and efficacy of BEKINDA 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

“We are excited to initiate this study of BEKINDA for IBS-D, a debilitating disorder affecting millions of people worldwide with few approved therapies and a significant unmet medical need,” said Gilead Raday, RedHill’s Chief Operating Officer. “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 US, with top-line results expected during the second half of this year.”

BEKINDA is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. RedHill is pursuing clinical studies with two dose strengths of BEKINDA, a 24mg dose and a 12mg dose. 5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA, have been shown to slow intestinal transit time in humans. Alosetron (Lotronex), a 5-HT3 antagonist of the same class of drugs as ondansetron, the active ingredient in BEKINDA, has been approved for the treatment of women with severe chronic IBS-D but is under a restricted prescribing (REMS) program due to potential severe side effects. Ondansetron, approved by the US FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies and, in light of its good safety profile, RedHill believes that BEKINDA, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.

The randomised, double-blind, 2-arm parallel group Phase II clinical study is designed to evaluate the safety and efficacy of BEKINDA 12 mg in patients suffering from IBS-D. The study is expected to be conducted in 12 clinical sites in the U.S. and to enroll 120 patients who will be randomised 60:40 to receive either BEKINDA 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per FDA guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.

 

 





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