RedHill宣布与NIH合作研发治疗埃博拉病毒的潜在疗法

Redhill Biopharma Ltd NASDAQ:RDHL Pharmaceutical, Biotechnology,医药,生物科技
发布于: 7 月 14, 2016

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,该公司今日宣布与美国国家过敏与传染病研究所(NIAID)签署合作研发协议,其目的旨在评估RedHill用于治疗埃博拉病毒病的专有实验性疗法。NIAID是美国国家卫生院(NIH)的一部分。

此次研究合作是在RedHill联合NIAID针对RedHill专有实验性疗法所进行初步非临床试验取得积极结果后达成的。此次合作研究的目的旨在通过对比积极治疗方法和安慰剂组的病毒载量和细胞因子水平来评估其生存结果和疾病的严重程度。如果取得成功的话,那么该项研究将用于为获准使用动物规则办法而与美国食品药物管理局所进行协商提供支持数据。按照FDA规定,动物规则法的使用只有当人类疗效研究无法进行(这种实验的开展是不道德或不可行的)之时才能获准。

埃博拉病毒病是一种严重且往往会致命的疾病,这种疾病可导致人类患上严重的出血热,且其死亡率高达25-90%。目前还没有获得FDA批准的埃博拉病毒病治疗药物。

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择权;(viii) 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;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 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]

医药 生物科技