RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) 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，该公司宣布对RHB-105三向交叉药代动力学（PK）研究中的18名受试者（健康志愿者）首次给药，该项研究旨在评估RHB-105活性物质相对于计画验证性三期试验（阿莫西林和奥美拉唑双重疗法）和RHB-105食物效应研究中比较物的生物利用度。
RHB-105单剂量三向交叉药代动力学研究中的第一组受试者已给药，进而与RHB-105验证性三期试验和针对健康志愿者的食物效应研究中的活性比较剂进行对比。
RHB-105针对幽门螺旋杆菌感染的验证性三期试验将在今年4月份之前启动，但这取决于监管部门的批准及支持性PK研究的完成。
在取决于成功结果情况下，验证性三期研究和支持性PK研究预计将构成RHB-105美国新药申请所需的组合包。
RHB-105的首项三期试验成功的证实其在幽门螺旋杆菌感染方面的治疗率高达89.4%，进而为RHB-105相对于当前标准护理（SoC）疗法的潜在优异疗效提供了支援。
根据GAIN法，RHB-105已获得了FDA的QIDP认证，包括快速通道开发、新药申请优先审查及美国市场排他性的扩大，这一授权的期限为8年。
幽门螺旋杆菌感染是慢性胃炎、消化性溃疡病、胃癌和粘膜相关淋巴组织淋巴瘤的主要发病因，且预计会对全球超过一半的成年人产生影响。
按照目前的品牌价格，2015年全球和美国幽门螺旋杆菌根除治疗方面的市场潜力估计分别约为48.3亿美元和14.5亿美元。
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已与Concordia就Donnatal®签署美国地区的联合促销协定，Donnatal®是一种用于治疗IBS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) -利紮曲坦口服薄膜制剂，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 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.
| 公司联络人： | 投资者关系联络人（美国） | |
| Adi Frish | Marcy Nanus | |
| 业务发展和许可高级副总裁 | 高级副总裁 | |
| RedHill Biopharma | The Trout Group | |
| +972-54-6543-112 | +1-646-378-2927 | |
| [email protected] | [email protected] |
