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。本公司今天公布，RHB-104克羅恩病（MAP美國試驗）已經舉行預先計劃的獨立數據和安全監測委員會安全性和療效評估會議，會議結束後，公司收到獨立數據安全監測委員會的一致性積極建議，建議試驗繼續按計劃進行。
獨立數據安全監測委員會審核了首批222名已經完成三期MAP美國試驗26周評估的受試者的安全性和療效數據，RedHill對這些數據尚不知情。
迄今爲止，計劃的410名受試者已有超過300名在三期MAP美國試驗中完成隨機分配。
非盲延伸三期試驗（MAP美國2試驗）正在進行中，受試者是MAP美國試驗中接受爲期26周參加者不知情的研究之後依然沒有緩解的患者。
RedHill醫學總監Ira Kalfus醫學博士稱：“RHB-104是克羅恩病潜在突破性新療法。獨立數據安全監測委員會已經審核了三期MAP美國試驗的非盲中期安全性和活動結果，該委員會給出的一致性建議令我們備受鼓舞，委員會建議計劃的所有410名受試者隨機分配，在不改變協議、研究者手册、試驗做法和知情同意書的情况下繼續進行試驗。我們將繼續招募受試者幷預計將在2018年上半年完成所有受試者招募。我想要對獨立數據安全監測委員會對試驗數據的獨立專業評估和積極反饋意見致以感謝。”
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) 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; (xiv) 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。
公司联络人：
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系联络人（美国）：
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
