Redhill Biopharma Ltd (NASDAQ: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12毫克BEKINDA® (RHB-102)治療腹瀉型腸易激綜合征的二期試驗完成招募最後一名患者。
試驗結果預計將在2017年第三季度發佈。
隨機雙盲安慰劑對照三期試驗正評估12毫克BEKINDA®治療127名美國腸易激綜合征患者的安全性和療效。
腸易激綜合征是最常見的胃腸疾病之一，據估測美國至少有3000萬人受腸易激綜合征困擾，其中超過40%屬於腹瀉型腸易激綜合征。
如果獲得批准，12毫克BEKINDA® 有望成為廣大腹瀉型腸易激綜合征患者優先選擇的日服一次的治療藥物，鎖定到2022年規模將超過10億美元的美國潛在市場。
24毫克BEKINDA® 治療急性腸胃炎和慢性胃炎的三期試驗（GUARD試驗）將於2017年第二季度發佈試驗結果。
RedHill將于2017年4月27日（周四）在紐約市舉辦BEKINDA®研發日活動和網絡直播，討論産品、適應症、潜在市場以及正在進行中的急性胃腸炎三期試驗以及腹瀉型腸易激綜合征二期試驗。可通過RedHill官方網站查看網絡直播及重播。
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已與Concordia就Donnatal®簽署美國地區的聯合推廣協議，Donnatal®是一種用于治療腸易激綜合征和急性小腸結腸炎的處方口服輔助藥物。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®, (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]
