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。本公司今天公布，RHB-104克罗恩病（MAP美国试验）已经举行预先计划的独立数据和安全监测委员会安全性和疗效评估会议，会议结束后，公司收到独立数据安全监测委员会的一致性积极建议，建议试验继续按计划进行。
独立数据安全监测委员会审核了首批222名已经完成三期MAP美国试验26周评估的受试者的安全性和疗效数据，RedHill对这些数据尚不知情。
迄今为止，计划的410名受试者已有超过300名在三期MAP美国试验中完成随机分配。
非盲延伸三期试验（MAP美国2试验）正在进行中，受试者是MAP美国试验中接受为期26周参加者不知情的研究之后依然没有缓解的患者。
RedHill医学总监Ira Kalfus医学博士称：“RHB-104是克罗恩病潜在突破性新疗法。独立数据安全监测委员会已经审核了三期MAP美国试验的非盲中期安全性和活动结果，该委员会给出的一致性建议令我们备受鼓舞，委员会建议计划的所有410名受试者随机分配，在不改变协议、研究者手册、试验做法和知情同意书的情况下继续进行试验。我们将继续招募受试者并预计将在2018年上半年完成所有受试者招募。我想要对独立数据安全监测委员会对试验数据的独立专业评估和积极反馈意见致以感谢。”
RedHill Biopharma Ltd介绍：
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，主要专注于开发并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) TALICIATM (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，正在进行验证性三期试验；(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，已经完成治疗多发性硬化症的IIa期试验并获得非结核性分枝杆菌感染的合格感染疾病产品资格；(iii)BEKINDA@ (RHB-102) -日服一次的昂丹司琼口服药片制剂，急性肠胃炎和胃炎三期试验取得成功结果，正在进行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，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，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; (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]
