On April 27, 2017, RedHill Biopharma Ltd (NASDAQ: RDHL) held an R&D Day highlighting for investors the clinical and commercial attributes of BEKINDA® (RHB-102). BEKINDA is an oral, extended-release, once-daily formulation of the antiemetic drug ondansetron. The drug is currently being examined as a treatment for acute gastroenteritis and gastritis in a Phase 3 clinical trial known as the GUARD study. GUARD completed enrollment in February 2017 and top-line data are expected in June 2017. A separate Phase 2 study investigating the drug as a treatment for diarrhea-predominant irritable bowel syndrome (IBS-D) is also ongoing, with top-line data expected in the third quarter 2017.
Quick Background on BEKINDA®
BEKINDA is an oral, bi-modal, extended-release, once-daily formulation of the antiemetic drug ondansetron. Ondansetron is a selective serotonin 5-HT3 receptor type antagonist originally approved in January 1991 and sold under the brand name Zofran® by GlaxoWellcome Inc. for the prevention of chemotherapy and radiation-induced nausea and vomiting, and the prevention of postoperative nausea and vomiting. Zofran® sees significant use in the prevention of nausea and vomiting, largely due to the drug’s benign safety profile and general utility in preventing emesis. The patent expired in December 2006, but not before the drug achieved peak sales that year of $1.7 billion.
The recommended dose of ondansetron for the prevention of radiation-induced nausea and vomiting is one 8 mg tablet one to two hours before therapy, then 8 mg orally every eight hours for five days post-treatment. For prevention of chemotherapy-induced nausea and vomiting, patients are recommended to take 8 mg twice daily. Peak plasma concentration occurs approximately 90 minutes following oral administration. The half-life is approximately 3-4 hours.
RedHill’s BEKINDA is a once-daily oral formulation of ondansetron designed to provide ease of use and greater patient compliance over the generic twice-daily formulation. The graph below shows the pharmacokinetic comparison between Zofran® (ondansetron) and BEKINDA. BEKINDA offers virtually identical onset of action to the standard 8 mg Zofran® tablet, but with superior TMAX and AUC that allows for once-daily dosing. The data also shows a low coefficient of variance among patients.
