RedHill Biopharma Ltd.
RedHill Biopharma Announces Successful PK Study with BEKINDA(TM) 12 mg and Submission to FDA of IBS-D Phase II Study Protocol
DGAP-News: RedHill Biopharma Ltd. / Key word(s): Study results Press Release RedHill Biopharma Announces Successful PK Study with BEKINDA(TM) 12 mg and Submission to FDA of IBS-D Phase II Study Protocol
TEL-AVIV, Israel, February 11, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) (“RedHill” or the “Company”), an Israeli biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, announced today the successful completion of a first-in-man pharmacokinetic (PK) study of BEKINDA(TM) 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(TM) 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations. BEKINDA(TM) 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(TM), a 24 mg dose and a 12 mg dose. A Phase III study with BEKINDA(TM) 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(TM) 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(TM) 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(TM) 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(TM) 12 mg formulation with that of the previously studied BEKINDA(TM) 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. Gilead Raday, RedHill Senior VP Corporate and Product Development, said: “We are very pleased about adding IBS-D to the indications targeted by BEKINDA(TM) and believe that there is a clear need for better therapies for IBS-D patients. The potential of BEKINDA(TM) 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(TM) 12 mg as a preferred therapy in the IBS-D U.S. market estimated to exceed $1 billion by 2020.” 5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA(TM), have been shown to slow intestinal transit time in humans . Alosetron (Lotronex(R)), 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 studies and, in light of its good safety profile, RedHill believes that BEKINDA(TM), if approved, has the potential to be a preferred once-daily treatment for patients suffering from IBS-D. About BEKINDA(TM) (RHB-102): About RedHill Biopharma Ltd.: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (vii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (ix) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (x) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xi) competitive companies and technologies within the Company’s industry; and (xii) the impact of the political and security situation in Israel on the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 26, 2015. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
2016-02-11 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |