RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物制药公司,主要专注于开发并销售炎症性疾病和胃肠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。该公司今日宣布最近发表的一篇文章证实了RHB-104在鸟型分枝杆菌亚种副结核(MAP)感染相关克罗恩病治疗中的潜在疗效。
这篇文章发表在同行评审期刊Gut Pathogens上,由来自中佛罗里达大学医学院伯内特生物医学科学院的科学家撰写。
RHB-104是一种专有的具备潜在突破性的含有强效胞内、抗分枝杆菌和抗炎性质的口服抗生素混合药,目前正在进行治疗克罗恩病的首个三期试验及治疗多发性硬化症的IIa期试验。
这篇文章得出的结论是RHB-104活性成分的三重组合可在抑制分枝杆菌的生长中发挥很好的协同作用,进而可能会诞生一种新的有效疗法来治疗与鸟型分枝杆菌亚种副结核(MAP)感染有关的克罗恩病。
RedHill首席执行管Dror Ben-Asher表示:“我要感谢奥兰多中佛罗里达大学的科学家。他们所写的这篇文章为用于克罗恩病治疗的RHB-104的持续开发提供了支援。RHB-104是RedHill开发的旗舰胃肠道项目之一,目前正在美国和其他国家进行第三阶段研究,也就是所谓的MAP美国研究。在从计划招募的总计270名患者中招募近200名患者情况下,MAP美国三期研究目前进展顺利,且我们预计会在2016年下半年公布该项研究的中期数据和安全监测委员会分析结果。继2016年3月份公布令人鼓舞的初步数据后,我们预计还将在今年下半年公布RHB-104用于多发性硬化症的IIa期概念验证研究的最终结果。”
RedHill Biopharma Ltd介绍:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的新兴生物医药公司,主要专注于开发幷销售治疗炎症性疾病和肠胃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。公司目前的产品管线包括:(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,正在进行首个三期试验以及治疗多发性硬化症的二a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uPA抑制剂口服胶囊,是首创新药,靶向为胃肠和其他实体瘤;(vii) RP101 – Hsp27抑制剂口服药片,是处于二期试验阶段的首创新药,靶向为胰腺癌和其他胃肠癌,RedHill拥有该药物的收购选权;(viii) 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;以及(ix) RHB-101 -心血管药物卡维地洛日服一次的口服药片制剂。
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 develop ment 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 US 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 st udies 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 Secu rities 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.
公司连络人:
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系连络人(美国):
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]