RedHill Biopharma Ltd.（納斯達克：RDHL）（特拉維夫股票交易所：RDHL）（“RedHill”或“公司”）是一家專業生物製藥公司，主要專注于胃腸疾病和炎症性疾病及癌症治療方面、處于後期臨床試驗階段的專有口服小分子藥物的開發和商業化。本公司今天公布目前正在美國進行的RHB-104克羅恩病鳥型分枝杆菌副結核杆菌亞種（美國MAP）首項三期試驗的受試者人數已經由410人减少至大約325人。到目前爲止已有322名受試者入組，同時保持了80%以上的統計功效和15%的處理效應。
對當前盲測數據混合功效及統計學家和重要意見領袖等專家給出的進一步意見進行了審核，結果顯示治療成功總數與預定的預期治療結果一致，幷且本試驗能招募足够的受試者來證明療效。
預計將提前一年完成開發計劃，患者入組預計將在2017年11月完成，試驗結果預計將在2018年中發布。估計節省成本$1400萬元。
RedHill已于2017年10月2日召開電話會議和網絡直播來審核RHB-104開發計劃以及美國MAP三期試驗的變動。
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RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd(納斯達克：RDHL)(特拉維夫股票交易所：RDHL)是一家總部位于以色列的專業生物醫藥公司，主要專注于腸胃疾病和炎症性疾病以及癌症方面後期臨床試驗階段的專有口服小分子藥的開發和商業化。RedHill在美國推廣三款胃腸産品——腸易激綜合征和急性小腸結腸炎口服處方輔助藥物Donnatal®，醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®，以及成人胃食管反流疾病和其他胃腸疾病的質子泵抑制劑—49.3毫克埃索美拉唑鍶遲釋膠囊。RedHill目前處于臨床階段的産品管綫包括：(i)TALICIA™(RHB—105)—幽門螺杆菌感染口服混合藥，首項三期試驗獲得成功，正在進行驗證性三期試驗；(ii)RHB—104—克羅恩病口服混合藥，正在進行首項三期試驗，已經完成治療多發性硬化症的概念驗證IIa期試驗幷計劃進行治療非結核性分枝杆菌感染的關鍵性三期試驗；(iii)BEKINDA®(RHB—102)—日服一次的昂丹司瓊口服藥片製劑，急性腸胃炎和胃炎三期試驗取得成功結果，正在進行治療腹瀉型腸易激綜合征的二期試驗；(iv)RHB—106—腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v)YELIVA® (ABC294640)—二期階段的口服SK2選擇性抑制劑，是首創新藥，靶向爲多種腫瘤、炎症性和胃腸道適應症；(vi)MESUPRON—處于二期試驗階段的口服蛋白酶抑制劑，是首創新藥，靶向爲胰腺癌和其他實體瘤；；(vii)RIZAPORT® (RHB—103)—利扎曲坦口服薄膜製劑，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，通過歐洲分散審批程序在兩個歐盟國家獲得上市許可。欲瞭解與本公司有關的更多資訊，請訪問：www.redhillbio.com。
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) changes in the outcomes of our clinical trials resulting from changes in the size of the trials, and the accuracy of projected cost savings from changes to clinical trials; (ii) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts and projected cost savings from any changes to these trials; (iii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iv) 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; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (vi) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vii) the Company’s ability to establish and maintain corporate collaborations; (viii) 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; (ix) 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; (x) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (xi) 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; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xiii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiv)the Company’s Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill’s investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xv) competitive 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 Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. 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.
注：該新聞稿的唯一官方版本是本公司發布的英文原版稿件。本摘要和翻譯版本僅爲方便閱讀之目的。
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公司聯絡人： Adi Frish 業務發展和許可高級副總裁 RedHill Biopharma +972-54-6543-112 |
投資者關係聯絡人（美國）： Marcy Nanus 高級副總裁 The Trout Group +1-646-378-2927 |
