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RedHill Biopharma completes pharmacokinetic study with BEKINDA 12 mg formulation

RedHill Biopharma has completed a first-in-man pharmacokinetic (PK) study of BEKINDA 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

RedHill further announced the submission to the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) protocol for the Phase II clinical study with BEKINDA 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations.

BEKINDA is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. RedHill is developing two dose strengths of BEKINDA, a 24 mg dose and a 12 mg dose.

A Phase III study with BEKINDA 24 mg for acute gastroenteritis and gastritis is also ongoing in the U.S., with top-line results expected in the second half of 2016.

The randomized, 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 will be conducted in 12 clinical sites in the U.S. and is expected to enroll 120 patients who will be 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 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, per FDA guidance definition.

RedHill recently concluded a first-in-man pharmacokinetic (PK) study with BEKINDA 12 mg proprietary formulation, intended to be administered in the Phase II study for IBS-D. The PK study compared the PK profile of BEKINDA 12 mg formulation with that of the previously studied BEKINDA 24 mg to determine the relative bioavailability and dose-linearity between the two.

The PK study confirmed the results of earlier RedHill studies demonstrating equivalent dose-adjusted bioavailability and dose-linearity between the two strengths.

RedHill senior VP of corporate and product development Gilead Raday said: "We are very pleased about adding IBS-D to the indications targeted by BEKINDA and believe that there is a clear need for better therapies for IBS-D patients. The potential of BEKINDA 12 mg to provide an effective and safe once-daily treatment is exciting, and is supported by clinical research conducted with ondansetron.

A successful outcome in the Phase II study, planned to be initiated in the coming weeks, could potentially position BEKINDA 12 mg as a preferred therapy in the IBS-D U.S. market estimated to exceed $1 billion by 2020."

Irritable bowel syndrome (IBS) is a chronic multifactorial disorder characterized 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 U.S.1 Certain factors that may alter gastrointestinal function can contribute to IBS symptoms include 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 may suffer from IBS2, of which over 50% are cases of IBS-D3. The U.S. potential market for IBS-D treatments is estimated to exceed $1.25 billion by 2020.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA, have been shown to slow intestinal transit time in humans4. Alosetron (Lotronex), a 5-HT3 antagonist, has been approved for the treatment of IBS in women with severe chronic IBS-D but is under a restricted prescribing program due to potential severe side effects.

Ondansetron, approved by the U.S. FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies6 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 patients suffering from IBS-D.

About BEKINDA (RHB-102):

BEKINDA is a patent-protected, extended-release (24 hours) oral pill formulation of the active ingredient ondansetron. RedHill is developing BEKINDA for the treatment of acute gastroenteritis and gastritis as well as for diarrhea-predominant irritable bowel syndrome (IBS-D) and for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively).

A Phase III clinical study with BEKINDA for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in mid-late 2016. RedHill plans to initiate a Phase II study with BEKINDA for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

RedHill is also pursuing marketing approval of BEKINDA in Europe for the oncology support indications of CINV and RINV prevention, pending additional feedback from EU member states as to whether additional clinical and CMC work is required.