RedHill Biopharma Ltd. (NASDAQ; RDHL) (TASE: RDHL) 宣布已經在美國啟動二期臨床試驗，評估12毫克BEKINDA™ 治療腹瀉型腸道易激綜合徵患者的安全性和療效。
BEKINDA™ (RHB-102)介紹：
BEKINDA™ 是受專利保護的、昂丹司瓊緩釋（24小時）口服藥片製劑。 BEKINDA™治療急性腸胃炎和慢性胃炎的三期臨床試驗正在美國進行中，預計將在2016年下半年發布試驗結果。 BEKINDA™已經啟動治療腹瀉型腸道易激綜合徵的二期試驗。 RedHill還在歐洲尋求將BEKINDA™用於預防化療和放射療法引起的噁心嘔吐的上市許可，目前正在等待歐盟國家的反饋意見，以決定是否需要展開進一步的臨床和化學、製造與控制方面工作。
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位於以色列的新興生物醫藥公司，致力於開發和商業化治療炎症性疾病和腸胃疾病（包括癌症）的處於後期臨床試驗階段、專有的、口服的小分子藥。公司目前的產品管線包括：(i) RHB-105 -治療幽門螺桿菌感染的口服混合藥，首個三期試驗獲得成功；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首個三期試驗以及治療多發性硬化症的二a期概念驗證試驗；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗，以及治療腹瀉型腸易激綜合徵的二期試驗；(iv) RHB-106 -腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640 ) -口服SK2選擇性抑製劑，是首創新藥，靶向為多種腫瘤、炎症性和胃腸道適應症，已經啟動治療難治的/惡化的擴散性的大B細胞淋巴瘤的一/二期試驗；(vi) MESUPRON® – 處於二期試驗階段的uPA抑製劑口服膠囊，是首創新藥，靶向為胃腸和其他實體瘤；(vii) RP101 – Hsp27抑製劑口服藥片，是處於二期試驗階段的首創新藥，靶向為胰腺癌和其他胃腸癌，RedHill擁有該藥物的收購選擇權；(viii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜製劑，用於治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，2015年10月獲准在德國上市；以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
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 develop ment 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 Company’s ability to acquire products approved for marketing in the US that achieve commercial success and build its own marketing and commercialization capabilities; (vii) 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 st udies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) 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 Secu rities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. 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.
