Redhill Biopharma Ltd (NASDAQ: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12毫克BEKINDA® (RHB-102)治疗腹泻型肠易激综合征的二期试验完成招募最后一名患者。
试验结果预计将在2017年第三季度发布。
随机双盲安慰剂对照三期试验正评估12毫克BEKINDA®治疗127名美国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，据估测美国至少有3000万人受肠易激综合征困扰，其中超过40%属于腹泻型肠易激综合征。
如果获得批准，12毫克BEKINDA® 有望成为广大腹泻型肠易激综合征患者优先选择的日服一次的治疗药物，锁定到2022年规模将超过10亿美元的美国潜在市场。
24毫克BEKINDA® 治疗急性肠胃炎和慢性胃炎的三期试验（GUARD试验）将于2017年第二季度发布试验结果。
RedHill将于2017年4月27日（周四）在纽约市举办BEKINDA®研发日活动和网络直播，讨论产品、适应症、潜在市场以及正在进行中的急性胃肠炎三期试验以及腹泻型肠易激综合征二期试验。可通过RedHill官方网站查看网络直播及重播。
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已与Concordia就Donnatal®签署美国地区的联合推广协议，Donnatal®是一种用于治疗肠易激综合征和急性小肠结肠炎的处方口服辅助药物。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®, (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]
