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12毫克BEKINDA® (RHB-102)治療腹瀉型腸易激綜合征的二期臨床試驗取得積極結果。
12毫克BEKINDA®[i] 二期試驗成功達到主要終點，相比安慰劑以19.4%的絕對差异改善糞便性狀主要功效結果，幷且對比之前公布的Xifaxan® (利福昔明)和Viberzi® (伊盧多啉)[ii]試驗結果更好。
腸易激綜合征是最常見的腸胃疾病之一。據估測美國大約有3000萬人受此病困擾，其中50%以上腹瀉型腸易激綜合征患者。2013至2016年期間美國腹瀉型腸易激綜合征市場規模增長了大約550%。
RedHill打算進行12毫克BEKINDA®三期試驗，幷計劃在2018年初與美國食品藥品監督管理局會面討論在美國獲得上市許可的路徑。
試驗結果仍視乎完成《臨床試驗報告》中的獨立審核和分析而定。
此外，在首項三期試驗取得成功幷與美國食品藥品監督管理局進行積極的指導意見會議之後，RedHill正在設計24毫克BEKINDA® 用于治療急性胃腸炎和慢性胃炎新藥申請的驗證性三期試驗。
RedHill醫學總監Terry F. Plasse醫學博士說道：“二期試驗所取得的結果令我們備受鼓舞，結果顯示12毫克BEKINDA®可能成爲腹瀉型腸易激綜合征患者的有效治療藥物，我們期待與美國食品藥品監督管理局討論在美國獲得上市許可的路徑。儘管近期已有腹瀉型腸易激綜合征新藥獲得批准，但這一適應症對安全有效的新藥物依然明顯存在未滿足之醫學需求。我想要對參與本次試驗的患者和醫師致以感謝。我們將繼續不斷努力推動12毫克BEKINDA®儘快上市。”
RedHill顧問委員會成員、前Furiex Pharmaceuticals總裁兼首席醫學官June S. Almenoff醫學博士補充道：“12毫克BEKINDA®在本次試驗中展現了非常良好的安全性。如果本次試驗的安全性和療效結果能够在計劃中的關鍵性試驗中得到複製，幷且在疼痛感上也取得優勢，那麽12毫克BEKINDA®在獲得批准之後有望成爲腹瀉型腸易激綜合征新的標準治療藥物。”
本公司已于2017年10月3日召開電話會議討論BEKINDA®腹瀉型二期試驗的結果。重聽電話會議及查看幻燈片演示文稿，請訪問公司網站 http://ir.redhillbio.com/events.cfm，鏈接有效期爲30天。
RedHill Biopharma Ltd.簡介：
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®，以及治療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片劑，急性腸胃炎和慢性胃炎三期試驗以及腹瀉型腸易激綜合征二期試驗取得成功結果；(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，已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 and projected cost savings from any changes to these trials; (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供方便閱讀之目的。
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[i] BEKINDA® 爲試驗性新藥，尚未上市銷售。
[ii] Xifaxan® (利福昔明) 開藥信息：www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf;；Viberzi® (伊盧多啉) 開藥信息：www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf；已公布的三期試驗的平均絕對差异；BEKINDA®二期試驗結果與已獲得批准的腹瀉型腸易激綜合征藥物所披露的試驗數據之間進行理論對比，視作觀察BEKINDA®療效的總基準，不應視作直接和/或同級比較，因爲試驗設計、患者群和治療期各不相同。例如，Xifaxan®三期試驗提及的療效終點是在給藥兩周後的四周期間進行評估，Viberzi®三期試驗提及的療效終點是在給藥之後評估，幷且評估時間長達12周。 這些試驗幷非對同一患者群進行頭對頭研究。
