DGAP-News

RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA(R) Phase II Study for IBS-D - Seite 2

BEKINDA^(R) is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA^(R) 12 mg in adults over the age of 18 with IBS-D. The study enrolled 127 subjects in 16 U.S. clinical sites. Top-line results are expected in the third quarter of 2017.

Subjects enrolled in the Phase II IBS-D study were randomized 60:40 to receive either BEKINDA(R) 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.

IBS is one of the most common gastrointestinal disorders^[2]. It is estimated that at least 30 million Americans suffer from IBS^[3], of which over 40% are cases of IBS-D^[4]. The U.S. potential market for IBS-D treatments is estimated to exceed $1 billion by 2022^[5].


5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA^(R), have been shown to slow intestinal transit time in humans^[6]. Alosetron (Lotronex^(R)), a 5-HT3 antagonist of the same class of drugs as ondansetron, has been approved by the FDA for the treatment of women with severe chronic IBS-D, but is under a restricted prescribing (REMS) program due to potential severe side effects^[7]. Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies^[8] and, in light of its safety profile, RedHill believes that BEKINDA^(R), if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.