RedHill Biopharma Ltd. (纳斯达克：RDHL) (特拉维夫股票交易所：RDHL) (“RedHill”或“公司”)是一家專業生物製藥公司，主要專注于開發幷銷售胃腸疾病和炎症性疾病及癌症治療方面的處于後期臨床試驗階段的專有口服小分子藥物。本公司今天宣布24毫克BEKINDA®(RHB-102)治療急性胃腸炎和胃炎的三期GUARD 試驗取得積極結果。
本試驗成功達到治療急性胃腸炎功效的主要終點，幷發現BEKINDA®用于這一適應症安全幷且耐受性良好。
這一隨機雙盲安慰劑對照三期GUARD試驗評估了24毫克BEKINDA®治療急性胃腸炎和胃炎的療效和安全性。321名成人和年齡在12歲以上的兒童受試者在美國21個臨床基地登記，幷隨機按照60:40的比例分配到24毫克BEKINDA®組或安慰劑組。本試驗的主要終點是：服用第一劑試驗藥物一直到用藥24小時後，不再嘔吐、不用急救藥品以及沒有接受靜脉補液的受試者比例與安慰劑組進行對比。
Northwell Health急診醫學專家、理學碩士兼醫學博士以及BEKINDA®三期GUARD試驗的帶頭研究員Robert A. Silverman說道：“三期GUARD試驗的積極結果顯示24毫克BEKINDA®對治療急性胃腸炎和胃炎有益，幷且能够爲患者提供長達24小時的緩解作用。胃腸炎在美國是一種非常常見的疾病，每年約有1.79億病例。如果獲得美國食品藥品監督管理局批准，那麽BEKINDA®有望成爲新的治療標準，幫助我們迅速有效地治療門診和急診患者。”
RedHill首席醫學官、醫學博士補充道：“我們很高興三期GUARD試驗取得積極結果，該試驗實現了療效主要終點，幷顯示了24毫克GUARD具有安全性和良好耐受性。特別值得一提的是，從病人最初的噁心程度來看結果，我們在基綫情况下伴有嚴重噁心感的患者身上也看到了治療效果，意味著無論胃腸炎患者一開始的嚴重程度如何，該藥物都有效。我們將繼續分析數據，最終的臨床試驗報告預計將在2017年第三季度完成。我們期待向美國食品藥品監督管理局展示這些數據，幷探討24毫克BEKINDA®在美國獲得上市許可的途徑，以及在提交新藥申請之前是否還需要進行進一步的試驗。12毫克BEKINDA®腹瀉型腸易激綜合征二期試驗的結果預計將在2017年9月公布。我想要向參與Guard試驗的全體患者、研究員、臨床人員以及服務人員致以感謝，幷贊賞RedHill團隊實現了這一重要里程碑致。”
RedHill將在2017年6月21日（周三）美國東部時間上午8：00舉行電話會議和網絡直播，回顧三期GUARD試驗的結果。請訪問公司網站獲取參與電話會議和觀看網絡直播的相關信息：http://ir.redhillbio.com/events.cfm。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位于以色列的專業生物醫藥公司，主要專注于開發幷銷售治療腸胃疾病和炎症性疾病以及癌症方面的處于後期臨床試驗階段的專有口服小分子藥。RedHill在美國推廣兩款胃腸産品——治療腸易激綜合征和急性小腸結腸炎的口服處方輔助藥物Donnatal®，以及用于醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®。RedHill目前處于臨床階段的産品管綫包括：(i) RHB-105 -治療幽門螺杆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，正在進行首項三期試驗以及治療多發性硬化症的IIa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，靶向爲胃腸和其他實體瘤；(vii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜製劑，用于治療急性偏頭痛，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。欲瞭解與本公司有關的更多資訊，請訪問：www.redhillbio.com。
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 market Donnatal® and 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 of 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; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) 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。
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
[email protected]
投資者關係聯絡人 （美國）
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
