RedHill Biopharma的23期新冠肺炎研究在墨西哥获得批准

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　　redhill biopharma的2/3期新冠肺炎研究在墨西哥获得批准

　　针对opaganib的全球2/3期研究计划在40个临床地点招募270名新冠肺炎重症患者

　　全球2/3期研究已在墨西哥、英国和俄罗斯，在意大利和巴西等其他一些国家正在接受审核

　　在美国的一项针对重症新冠肺炎患者的2期平行研究的患者招募工作已完成约50%，预计将于本月完成

　　计划最早在2020年第4季度提交全球紧急用药申请

　　以色列特拉维夫和北卡罗来纳州罗利, Aug. 13, 2020 (GLOBE NEWSWIRE) -- 特种生物制药企业RedHill Biopharma ltd.(纳斯达克：RDHL)(以下称RedHill或该公司)今天宣布，墨西哥联邦卫生风险保护委员会(COFEPRIS)已批准该公司的临床试验授权(CTA)申请以进行2/3阶段研究，评估opaganib(Yeliva®，ABC294640)1对重度SARS-CoV-2(新型冠状病毒)感染(新冠肺炎的致病原因)和肺炎住院患者的疗效。

　　RedHill的研究目前已在墨西哥、英国和俄罗斯获得批准，并正在意大利、巴西和其他国家接受审核。目前已制定计划将这项研究进一步扩展到更多国家。

　　随着新出现的感染激增并带来新的重症病例，药物开发人员必须以严格设计和迅速实施的研究作出响应。opaganib是目前正在试验用于重症新冠肺炎患者的最先进的新型药物之一，RedHill首席运营官Gilead Raday表示。 与此同时，我们预计在本月完成正在美国进行的opaganib二期研究的患者招募。如果上述研究成功，我们将力争最早在今年第四季度申请紧急用药授权。

　　这是一项多中心、随机、双盲、平行、安慰剂对照的2/3期研究(NCT04467840)，计划招募270名需要住院治疗和辅助供氧的新冠肺炎重症患者参与试验。受试者将以1:1的比例随机分组，接受opaganib或安慰剂用药，并按医护标准接受治疗。该研究的主要终点是评估在第14天时需要插管和呼吸机的患者比例。在大约100名受试者接受主要终点评估之后，一家独立数据安全监测委员会(DSMB)将进行解盲无效中期分析。

　　与此同时，在美国进行的opaganib二期临床研究的患者招募已完成约50%，预计将在本月全部完成。这项随机、双盲的安慰剂对照研究(NCT04414618)并非以统计显著性为目标，旨在招募40名需要住院治疗和辅助吸氧的新冠肺炎重症患者参与试验。

　　关于opaganib(ABC294640，Yeliva®)

　　opaganib是一种新的化学体，一种专有的首创性口服鞘氨醇激酶-2(SK2)选择性抑制剂，具有抗肿瘤、抗炎和抗病毒活性，针对多种肿瘤、病毒、炎症和肠道适应症。通过抑制SK2，opaganib可影响与癌细胞生长、病毒复制和病理炎症相关的多种蜂窝路径。

　　opaganib最初由美国Apogee Biotechnology Corp开发并在肿瘤、炎症、胃肠道和放射防护模型的多项临床前研究以及针对晚期实体肿瘤患者的一项1期临床研究中获得成功。

　　opaganib获得了美国FDA针对治疗胆管癌的罕见病用药批准，目前正在进行晚期胆管癌2a期研究评估和前列腺癌2期研究评估。此外，opaganib对于新冠肺炎的治疗效果目前也在评估中。

　　第一批使用opaganib的新冠肺炎重症患者的治疗结果已于近期公布2。对5例新冠肺炎重症患者的治疗结果分析显示，与同一医院回顾性配对病例对照组的患者相比，接受opaganib体恤用药治疗的患者在临床结果和炎症标志物方面均有显著获益。opaganib治疗组中的所有患者都在无需使用呼吸机的情况下出院，而对应的病例对照组中有33%的患者需要呼吸机。opaganib治疗组的经鼻高量氧疗脱机中位时间减少到10天，而匹配病例对照组则为15天。

　　临床前数据显示，opaganib具有抗炎和抗病毒活性，具有减少肺部炎症性疾病(如肺炎)和减轻肺纤维化损害的潜力。此前的几项临床前研究支持SK2在与冠状病毒类似的阳性单链RNA病毒复制转录复合物中的潜在作用，并且其抑制作用有可能抑制病毒复制。临床前体内研究2表明，通过降低支气管肺泡灌洗液中IL-6和TNF-α的水平，opaganib可降低流感病毒感染的病死率，并改善铜绿假单胞菌诱发的肺损伤。

　　opaganib的开发因美国联邦和州政府机构给予Apogee Biotechnology Corp.的拨款和合同而得到支持，相关机构包括NCI、BARDA、美国国防部和FDA罕见病药物开发办公室。

　　关于RedHill Biopharma

　　RedHill Biopharma Ltd.(纳斯达克：RDHL)是一家主要关注肠胃疾病治疗的特种生物制药企业。RedHill目前推广的胃肠药物包括：Movantik®——用于治疗阿片类药物引起的成人便秘3、Talicia®——用于治疗成人幽门螺杆菌(H. pylori)4感染和Aemcolo®——用于治疗成人旅行者腹泻6。RedHill的主要临床后期开发项目包括：(i)RHB-204，计划针对肺部非结核分枝杆菌(NTM)感染进行关键第3阶段研究;(ii)opaganib(Yeliva®)，首创性的SK2选择性抑制剂，针对多种适应症，正在进行新冠肺炎治疗的2/3期研究，以及针对前列腺癌和胆管癌进行2期研究;(iii)RHB-104，针对克罗恩氏病进行的3期首次研究取得了积极成果;(iv)RHB-102(Bekinda®)针对急性胃肠炎和胃炎3期研究取得了积极结果，针对IBS-D的2期研究也取得了积极结果;(v)RHB-106，一种胶囊状肠道制剂;以及(vi)RHB-107，一款处于第2阶段研究的首创性丝氨酸蛋白酶抑制剂，针对癌症和炎症肠胃病适应症，并且正在针对新冠肺炎治疗进行评估。有关该公司的更多信息，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, the risk that the clinical condition of the patients treated with opaganib will not continue to improve and may worsen, the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of the enrollment for this clinical study will be delayed; the risk that the Company will not initiate the Phase 2/3 study in Russia, Italy, the UK, Brazil and Mexico and will not expand this study to a multinational study with sites in additional countries; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in Israel, the U.S., Italy, Russia, the UK, Brazil, Mexico or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under the compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type 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 and Talicia®; (v) the Company’s ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo® ; (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 and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical 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 commercial products 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; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other 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 March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

　　注意：本新闻稿是公司以英文发布的官方新闻稿的译文，为方便查阅之目的而提供。

　　公司联系人：

　　Adi Frish

　　业务开发与授权高级副总裁

　　RedHill Biopharma

　　+9772-54-6543-112

　　adi@redhillbio.com

　　投资者关系联系人(美国)：

　　Timothy McCarthy，CFA、MBA

　　董事总经理、关系经理

　　LifeSci Advisors, LLC

　　+1-212-915-2564

　　tim@lifesciadvisors.com

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　　1Opaganib是一种试验性新药，尚未批准商业销售。

　　2Xia C.等。 神经氨酸激酶的短暂抑制对感染甲型流感病毒小鼠的保护作用。(Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice.) 《AntiviralRes.》，2018年10月;158:171-177。Ebenezer DL等人 铜绿假单胞菌可刺激细胞核鞘糖苷-1-磷酸的生成和肺炎症损伤的表观遗传调控。(Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury.) Thorax。2019年6月;74(6):579-591。

　　3 Movantik® (naloxegol)的完整处方信息请见： www.Movantik.com。

　　4 Talicia® (奥美拉唑镁、阿莫西林和利福布汀)的完整处方信息请见： www.Talicia.com。

　　5 Aemcolo® (利福霉素)的完整处方信息请见： www.Aemcolo.com。