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

IBS is one of the most common gastrointestinal disorders². It is estimated that at least 30 million Americans suffer from IBS³, of which over 40% are cases of IBS-D⁴. The U.S. potential market for IBS-D treatments is estimated to exceed $1 billion by 2022⁵.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA^®, have been shown to slow intestinal transit time in humans⁶. Alosetron (Lotronex^®), 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 effects⁷. Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies⁸ and, in light of its 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.

Top-line results from the Phase III study with BEKINDA^® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017. In February 2017, RedHill announced that the last patient had completed the treatment course and observation period in the randomized, double-blind, placebo-controlled GUARD study, which treated 320 adults and children over the age of 12 in 29 U.S. clinical sites.   

The Phase II study and the Phase III GUARD study with BEKINDA^® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About BEKINDA^® (RHB-102):
BEKINDA^® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. A Phase III clinical study of BEKINDA^® 24 mg formulation for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with patient treatment course and observation period completed and top-line results expected in the second quarter of 2017. A Phase II study with BEKINDA^® 12 mg formulation is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with patient enrollment completed and top-line results expected in the third quarter of 2017.