RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”) 是一家生物制药公司，主要专注于开发并销售胃肠疾病和炎症性疾病及癌症治疗方面的处于后期临床试验阶段的专有口服小分子药物。该公司今日提供BEKINDA®正在进行三期和二期临床试验方面更新，这两项试验分别针对BEKINDA®在急性胃肠炎和胃炎及腹泻型肠易激综合征方面的治疗潜力。
正在进行的针对急性胃肠炎和胃炎的三期临床试验和针对腹泻型肠易激综合征的二期临床试验的顶线结果预计将在2017年年中公布。
BEKINDA® 24毫克剂量（用于治疗急性胃肠炎和胃炎）的三期临床试验计划在美国招募总计320名受试者，该计划目前已完成三分之二。
BEKINDA® 12毫克剂量（用于治疗腹泻型肠易激综合征）的二期临床试验计划在美国招募总计120名受试者，该计划目前已完成约一半。
全球每年胃肠炎和胃炎治疗方面的潜在市场预计会超过6.5亿美元。
到2020年，美国腹泻型肠易激综合征治疗方面的潜在市场预计会超过13亿美元。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的新兴生物医药公司，主要专注于开发幷销售治疗炎症性疾病和肠胃疾病以及癌症方面的处于后期临床试验阶段的专有口服小分子药。 公司目前的专有产品管线包括：(i) RHB-105 -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首个三期试验以及治疗多发性硬化症的二a期概念验证试验；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂，正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验，以及治疗腹泻型肠易激综合征的二期试验；(iv) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640) -二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症；(vi) MESUPRON® – 处于二期试验阶段的uPA抑制剂口服胶囊，是首创新药，靶向为胃肠和其他实体瘤；(vii) RP101 – Hsp27抑制剂口服药片，是处于二期试验阶段的首创新药，靶向为胰腺癌和其他胃肠癌，RedHill拥有该药物的收购选择权；(viii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜制剂，用于治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，2015年10月获准在德国上市；以及(ix) RHB-101 -心血管药物卡维地洛日服一次的口服药片制剂。
前瞻性陈述
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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. 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 25, 2016. 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.
公司联络人：
Adi Frish
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
业务发展和许可高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
