RedHill Biopharma Ltd. (纳斯达克:RDHL) (特拉维夫股票交易所:RDHL) (“RedHill”或“公司”)是一家专业生物制药公司，主要专注于开发幷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。本公司今天宣布24毫克BEKINDA®(RHB-102)治疗急性胃肠炎和胃炎的三期GUARD 试验取得积极结果。
本试验成功达到治疗急性胃肠炎功效的主要终点，幷发现BEKINDA®用于这一适应症安全幷且耐受性良好。
这一随机双盲安慰剂对照三期GUARD试验评估了24毫克BEKINDA®治疗急性胃肠炎和胃炎的疗效和安全性。321名成人和年龄在12岁以上的儿童受试者在美国21个临床基地登记，幷随机按照60:40的比例分配到24毫克BEKINDA®组或安慰剂组。本试验的主要终点是：服用第一剂试验药物一直到用药24小时后，不再呕吐、不用急救药品以及没有接受静脉补液的受试者比例与安慰剂组进行对比。
Northwell Health急诊医学专家、理学硕士兼医学博士以及BEKINDA®三期GUARD试验的带头研究员Robert A. Silverman说道：“三期GUARD试验的积极结果显示24毫克BEKINDA®对治疗急性胃肠炎和胃炎有益，幷且能够为患者提供长达24小时的缓解作用。胃肠炎在美国是一种非常常见的疾病，每年约有1.79亿病例。如果获得美国食品药品监督管理局批准，那么BEKINDA®有望成为新的治疗标准，帮助我们迅速有效地治疗门诊和急诊患者。”
RedHill首席医学官、医学博士补充道：“我们很高兴三期GUARD试验取得积极结果，该试验实现了疗效主要终点，幷显示了24毫克GUARD具有安全性和良好耐受性。特别值得一提的是，从病人最初的恶心程度来看结果，我们在基线情况下伴有严重恶心感的患者身上也看到了治疗效果，意味着无论胃肠炎患者一开始的严重程度如何，该药物都有效。我们将继续分析数据，最终的临床试验报告预计将在2017年第三季度完成。我们期待向美国食品药品监督管理局展示这些数据，幷探讨24毫克BEKINDA®在美国获得上市许可的途径，以及在提交新药申请之前是否还需要进行进一步的试验。12毫克BEKINDA®腹泻型肠易激综合征二期试验的结果预计将在2017年9月公布。我想要向参与Guard试验的全体患者、研究员、临床人员以及服务人员致以感谢，幷赞赏RedHill团队实现了这一重要里程碑致。”
RedHill将在2017年6月21日（周三）美国东部时间上午8：00举行电话会议和网络直播，回顾三期GUARD试验的结果。请访问公司网站获取参与电话会议和观看网络直播的相关信息：http://ir.redhillbio.com/events.cfm。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的专业生物医药公司，主要专注于开发幷销售治疗肠胃疾病和炎症性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。RedHill在美国推广两款胃肠产品——治疗肠易激综合征和急性小肠结肠炎的口服处方辅助药物Donnatal®，以及用于医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®。RedHill目前处于临床阶段的产品管线包括：(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，正在进行首项三期试验以及治疗多发性硬化症的IIa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口服蛋白酶抑制剂，是首创新药，靶向为胃肠和其他实体瘤；(vii) 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。欲了解与本公司有关的更多资讯，请访问：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：该新闻稿的唯一官方版本是本公司发布的英文原版稿件。本摘要和翻译版本仅为方便阅读之目的。
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]
