RedHill Biopharma Announces Last Patient Visit in BEKINDA® Phase II Study for IBS-D

Top-line results are expected in September 2017 

• The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® (RHB-102) 12 mg in 127 U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D),with a primary endpoint of response in stool consistency as compared to baseline
• IBS is one of the most common gastrointestinal disorders, with up to 30 million American sufferers, of which over 50% are cases of IBS-D; The U.S. market for IBS-D therapies grew by approximately 550% between 2013-2016, to an estimated $473 million in 2016, and is expected to continue to grow by approximately 14% annually (2016 – 2022)
• If approved, BEKINDA® 12 mg has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D
• Positive top-line results from the Phase III GUARD study with BEKINDA® 24 mg for acute gastroenteritis and gastritis indicated that the study successfully met its primary endpoint, and BEKINDA® 24 mg was shown to be effective, safe and well tolerated in patients with acute gastroenteritis and gastritis

RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient enrolled in the Phase II study with BEKINDA® (RHB-102)(1) 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) has completed the treatment course and follow-up visit. Top-line results are expected in September 2017.

BEKINDA® is a proprietary, bimodal extended-release, once-daily, oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the efficacy and safety of BEKINDA® 12 mg in adults, 18 years and older, who suffer from IBS-D. The study enrolled 127 subjects at 16 clinical sites in the U.S.

Subjects enrolled in the study were randomized 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 stool consistency response as compared to baseline, per FDA guidance definition (a decrease of ≥50% in the number of days per week with at least one stool that has a consistency of 6 or 7 per the Bristol stool scale and no increase in abdominal pain over the week). 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 up to 30 million Americans suffer from IBS(3), of which over 50% are cases of IBS-D(4). The U.S. market for IBS-D therapies grew by approximately 550% between 2013-2016, to an estimated $473 million in 2016, and is expected to continue to grow with a compound annual growth rate (CAGR) of 14% (2016 – 2022)(5).

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal transit time in humans(6). Alosetron (Lotronex®), a different 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®, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D. 

In addition to the BEKINDA® 12 mg Phase II IBS-D program, RedHill recently announced positive top-line results from the Phase III GUARD study with BEKINDA® 24 mg, a different formulation of BEKINDA®. The Phase III GUARD study successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA® 24 mg was found to be safe and well tolerated in this indication.