RedHill Biopharma获准在俄罗斯进行2/3阶段新冠肺炎药物研究

继近期在英国获得批准和在意大利提交类似申请后，opaganib用于重症新冠肺炎患者的2/3期研究临床试验申请在俄罗斯获得批准
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此项2/3阶段研究力争在多达40个临床地点招募270名受试者；招募活动计划在本月晚些时候启动，并计划在2020年第4季度提交紧急使用授权申请
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同时，美国使用opaganib治疗重症新冠肺炎患者的2a期研究正在快速推进，目前已招募到25%以上的患者
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以色列也批准了将opaganib用于多达50名重症新冠肺炎患者的临床研究申请
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对匹配病例对照组患者相比，通过体恤用药治疗新冠肺炎重症患者显示出显著效果

以色列特拉维夫和北卡罗来纳州罗利, July 20, 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，俄罗斯联邦卫生部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（新冠肺炎的治病原因）和肺炎住院患者的疗效。英国最近也批准了同一研究；在意大利，类似申请正在接受审批。此外，已制定的相关计划将把这项研究进一步推广到更多国家。

“我们正在快速推进使用opaganib治疗新冠肺炎的临床开发计划；如果成功，我们计划在今年第四季度提交紧急使用授权申请。使用opaganib治疗新冠肺炎重症患者的2/3期研究已在两个国家获得监管批准，我们正在努力将该研究范围扩展到更多国家，” RedHill首席运营官Gilead Raday表示， “规划中的2/3阶段研究将在本月晚些时候启动，而且美国2a阶段研究患者招募人数已超过25%，在为新冠肺炎住院患者提供潜在疗效新型药物的竞争中，RedHill处于十分有利的领先位置。”

这是一项多中心、随机、双盲、平行、安慰剂对照的2/3期研究，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。

该公司还宣布，已获得以色列卫生部批准以启动一项研究，评估opaganib在多达50名重症新冠肺炎和肺炎患者中的治疗效果。

此外，在美国的一项使用opaganib进行随机、双盲、安慰剂对照2a阶段临床研究（NCT04414618）的受试者招募也正在进行中。这项研究旨在招募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。这次临床试验并非以统计意义为目的。

RedHill最近宣布，第一批使用opaganib的新冠肺炎重症患者的治疗结果已公布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，而配对病例对照组中有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，而配对病例对照组则为15天。

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对于冠状病毒（COVID-19）的治疗效果目前也在评估中。

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³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4、Talicia^®——用于治疗成人幽门螺杆菌（H. pylori） 5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阶段研究，以及针对前列腺癌和胆管癌进行2阶段研究；（iii）RHB-104，针对克罗恩氏病进行的第3阶段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第3阶段研究取得了积极结果，针对IBS-D的第2阶段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. and Israel Phase 2a clinical studies evaluating opaganib will not be successful; the risk that the Company will not initiate the Phase 2/3 study in the UK, Russia or Italy 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., Russia, the UK, Italy 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 Talicia^®, and Aemcolo^® and Movantik^®; (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：本新闻稿是该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。

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¹ Opaganib是一种试验性新药，尚未批准商业销售。

² 本文作者：Ramzi Kurd，医学博士，Shaare-Zedek医疗中心；Eli Ben-Chetrit，医学博士，Shaare-Zedek医疗中心和希伯来大学医学院；Hani Karameh，医学博士，Shaare-Zedek医疗中心，以及Maskit Bar-Meir，Shaare-Zedek医疗中心和希伯来大学医学院。请在此处查看全文：https://www.medrxiv.org/content/10.1101/2020.06.20.20099010v1?rss=1。

³ Xia C等人 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。《Antiviral Res.》，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。《Thorax》，2019年6月；74(6)：579-591。

⁴ 关于Movantik^®（naloxegol）的完整处方信息，请访问：www.Movantik.com。

⁵ 关于Talicia^®（奥美拉唑镁、阿莫西林和利福布汀）的完整处方信息，请访问：www.Talicia.com。

⁶ 关于Aemcolo^®（利福霉素）的完整处方信息，请访问：www.Aemcolo.com。 

source: RedHill Biopharma Ltd.