RedHill Biopharma Announces Two Oral Presentations on BEKINDA® 24 mg for acute gastroenteritis at the SAEM 2018 Annual Meeting
The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA® 24 mg 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 indication3. If approved for marketing by the
The first presentation, entitled ‘Treatment of Acute Gastroenteritis-Related Emesis with Bimodal Release Ondansetron (RHB-102)’, will be presented by
The second presentation, entitled ‘A 24 mg bimodal-release ondansetron pill (RHB-102) shows no evidence of QT interval prolongation’, will be presented by
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 and targets several gastrointestinal indications. A first Phase III clinical study with BEKINDA® 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) successfully met its primary endpoint. A Phase II study with BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) successfully met its primary endpoint.
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 successfully promote Donnatal® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mgand commercialize EnteraGam®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. 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
Senior VP Business Development & Licensing
1 The abstracts were authored by
2 BEKINDA® (RHB-102) is an investigational new drug, not available for commercial distribution.
3 Please click here for the full Phase III GUARD study results.
Source: RedHill Biopharma Ltd.