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 RHB-104克羅恩病鳥型分枝杆菌副結核杆菌亞種（the MAP US study）美國三期試驗第二次獨立數據安全監測委員會會議預計將在2017年7月底召開，幷將評估RHB-104對首批已經完成26周評估的222名受試者的安全性和療效。
數據安全監測委員會會議將包含中期療效分析，幷評估由于療效驚人成功提前結束試驗的方案。該委員會擬定在2017年8月初公布意見。
迄今爲止，正在進行的三期MAP美國試驗計劃招募的410名患者已有大約300名患者入組。
MAP美國試驗爲隨機雙盲、安慰對照三期試驗，評估RHB-104治療患有中度至嚴重克羅恩病的患者的安全性和療效，主要終點是第26周病情緩解。
正在進行的MAP美國非盲三期擴大試驗評估RHB-104治療已經完成26周三期MAP美國試驗但克羅恩病依然活躍的患者的安全性和功效。這些患者有機會在三期非盲擴大試驗中接受爲期52周的RHB-104治療。
RHB-104是具有潜在突破性的專有口服抗生素聯合治療藥物，具有强效的細胞內抗分枝杆菌及抗炎性能，靶向爲克羅恩病鳥型分枝杆菌副結核杆菌亞種細菌感染的疑似根源。
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) TALICIATM (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，正在進行驗證性三期試驗；(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，已經完成治療多發性硬化症的IIa期試驗幷獲得非結核性分枝杆菌感染的合格感染疾病産品資格；(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，靶向爲胃腸和其他實體瘤；(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。
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]
