RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物制药公司，主要专注于开发幷销售炎症性疾病和胃肠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。本公司今天宣布12毫克BEKINDA™治疗腹泻型肠易激综合征的二期临床试验的首位患者已经用药。
随机双盲安慰剂对照二期临床试验预计将在美国12个临床点招募120名受试者，旨在评估12毫克BEKINDA™用于治疗腹泻型肠易激综合征患者的安全性和疗效。
肠易激综合征是最常见的胃肠疾病之一，据估测美国有至少3000万人受该病困扰，其中50%以上患者患的是腹泻型肠易激综合征。
BEKINDA™ 是专有的止吐药昂丹司琼的缓释口服药片制剂，日服一次，靶向为多种胃肠适应症。RedHill正在进行24毫克和12毫克两种剂量的BEKINDA™临床试验，用于不同的适应症。24毫克BEKINDA™治疗急性胃肠炎和慢性胃炎的三期试验（GUARD试验）正在美国进行中，预计将在2016年年底发布试验结果。
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) -利扎曲坦口服薄膜制剂，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。
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.
公司连络人：
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系连络人（美国）：
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
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