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，主要专注于胃肠疾病和炎症性疾病及癌症治疗方面、处于后期临床试验阶段的专有口服小分子药物的开发和商业化。本公司今天公布12毫克BEKINDA® (RHB-102)治疗腹泻型肠易激综合征的二期临床试验取得积极结果。
12毫克BEKINDA®[i] 二期试验成功达到主要终点，相比安慰剂以19.4%的绝对差异改善粪便性状主要功效结果，幷且对比之前公布的Xifaxan® (利福昔明)和Viberzi® (伊卢多啉)[ii]试验结果更好。
肠易激综合征是最常见的肠胃疾病之一。据估测美国大约有3000万人受此病困扰，其中50%以上腹泻型肠易激综合征患者。2013至2016年期间美国腹泻型肠易激综合征市场规模增长了大约550%。
RedHill打算进行12毫克BEKINDA®三期试验，幷计划在2018年初与美国食品药品监督管理局会面讨论在美国获得上市许可的路径。
试验结果仍视乎完成《临床试验报告》中的独立审核和分析而定。
此外，在首项三期试验取得成功幷与美国食品药品监督管理局进行积极的指导意见会议之后，RedHill正在设计24毫克BEKINDA® 用于治疗急性胃肠炎和慢性胃炎新药申请的验证性三期试验。
RedHill医学总监Terry F. Plasse医学博士说道：“二期试验所取得的结果令我们备受鼓舞，结果显示12毫克BEKINDA®可能成为腹泻型肠易激综合征患者的有效治疗药物，我们期待与美国食品药品监督管理局讨论在美国获得上市许可的路径。尽管近期已有腹泻型肠易激综合征新药获得批准，但这一适应症对安全有效的新药物依然明显存在未满足之医学需求。我想要对参与本次试验的患者和医师致以感谢。我们将继续不断努力推动12毫克BEKINDA®尽快上市。”
RedHill顾问委员会成员、前Furiex Pharmaceuticals总裁兼首席医学官June S. Almenoff医学博士补充道：“12毫克BEKINDA®在本次试验中展现了非常良好的安全性。如果本次试验的安全性和疗效结果能够在计划中的关键性试验中得到复制，幷且在疼痛感上也取得优势，那么12毫克BEKINDA®在获得批准之后有望成为腹泻型肠易激综合征新的标准治疗药物。”
本公司已于2017年10月3日召开电话会议讨论BEKINDA®腹泻型二期试验的结果。重听电话会议及查看幻灯片演示文稿，请访问公司网站 http://ir.redhillbio.com/events.cfm，链接有效期为30天。
RedHill Biopharma Ltd.简介：
RedHill Biopharma Ltd(纳斯达克：RDHL)(特拉维夫股票交易所：RDHL)是一家总部位于以色列的专业生物医药公司，主要专注于肠胃疾病和炎症性疾病以及癌症方面、后期临床试验阶段的专有口服小分子药的开发和商业化。RedHill在美国推广三款胃肠产品——肠易激综合征和急性小肠结肠炎口服处方辅助药物Donnatal®，医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®，以及治疗胃食管反流疾病和其他胃肠疾病的质子泵抑制剂—49.3毫克埃索美拉唑锶迟释胶囊。RedHill处于临床阶段的产品管线包括：(i)TALICIA™(RHB—105)—幽门螺杆菌感染口服混合药，首项三期试验获得成功，正在进行验证性三期试验；(ii)RHB—104—克罗恩病口服混合药，正在进行首项三期试验，已经完成治疗多发性硬化症的概念验证IIa期试验幷计划进行治疗非结核性分枝杆菌感染的关键性三期试验；(iii)BEKINDA®(RHB—102)—日服一次的昂丹司琼口服片剂，急性肠胃炎和慢性胃炎三期试验以及腹泻型肠易激综合征二期试验取得成功结果；(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，靶向为胰腺癌和其他实体瘤；；(vii)RIZAPORT® (RHB—103)—利扎曲坦口服薄膜制剂，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，已通过欧洲分散审批程序在两个欧盟国家获得上市许可。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 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：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供方便阅读之目的。
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[i] BEKINDA® 为试验性新药，尚未上市销售。
[ii] Xifaxan® (利福昔明) 开药信息：www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf;；Viberzi® (伊卢多啉) 开药信息：www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf；已公布的三期试验的平均绝对差异；BEKINDA®二期试验结果与已获得批准的腹泻型肠易激综合征药物所披露的试验数据之间进行理论对比，视作观察BEKINDA®疗效的总基准，不应视作直接和/或同级比较，因为试验设计、患者群和治疗期各不相同。例如，Xifaxan®三期试验提及的疗效终点是在给药两周后的四周期间进行评估，Viberzi®三期试验提及的疗效终点是在给药之后评估，幷且评估时间长达12周。 这些试验幷非对同一患者群进行头对头研究。
