GlobeNewswire

2020-09-11 07:00

RedHill Biopharma的Opaganib显示出可完全抑制新型冠状病毒SARS-CoV-2

在人体支气管组织体外模型中培养三天后的测试结果表明,Opaganib可完全抑制SARS-CoV-2病毒复制,可与此项研究中的阳性对照remdesivir相媲美
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Opaganib作为一种潜在的新冠肺炎口服治疗药物,具有独特的优势,它结合有效的抗病毒和抗炎作用机制,靶向宿主细胞成分,并最大限度地降低耐药可能性
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采用opaganib治疗重症新冠肺炎的全球2/3期和美国2期临床研究正在进行中
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RedHill的第二个治疗新冠肺炎的候选药物RHB-107 (upammostat) 是一种新型丝氨酸蛋白酶抑制剂,它可强烈抑制同一模型中的SARS-CoV-2病毒复制,进一步支持今年晚些时候2/3期美国门诊研究的计划启动

以色列特拉维夫和北卡罗来纳罗利, Sept. 11, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL)(以下简称为“ RedHill”或“该公司”)是一家专业生物制药公司,该公司今天宣布,opaganib1显示出可有效抑制导致新冠肺炎的SARS-CoV-2病毒,在人体肺支气管组织的体外模型中完全阻止病毒复制。Opaganib是一种首创的口服鞘氨醇激酶-2 (SK2) 选择性抑制剂,具有双重抗炎和抗病毒活性,靶向宿主细胞成分,不受病毒突变的影响,从而最大限度地降低了耐药可能性。全球2/3期和美国2期临床研究目前正在评估Opaganib治疗重症新冠肺炎的功效。

与路易斯维尔大学预测医学中心合作,在一个人体支气管上皮细胞的3D组织模型 (EpiAirway) 中对Opaganib进行了研究,该模型在形态和功能上类似于人的呼吸道,且与用于发现SARS-CoV-2的模型相似2。该项研究旨在评估opaganib在体外抑制SARS-CoV-2病毒感染的功效,并且包括了已知具有抗病毒活性的remdesivir(瑞德西伟)阳性对照。

这项研究结果表明,opaganib对SARS-CoV-2具有明确而令人信服的抗病毒效果。与所有经过测试的化合物相比,包括阳性对照rerestvir,Opaganib表现出最高效活性。对感染SARS-CoV-2的细胞进行治疗,结果表明对病毒产生的抑制取决于剂量,且不会损害细胞膜的完整性(一项衡量细胞生存力和药物安全性的指标),这进一步证明了opaganib治疗新冠肺炎患者的巨大潜力。

本新闻稿的随附图表可在以下网址获取:https://www.globenewswire.com/NewsRoom/AttachmentNg/e60ced55-ca9d-4648-81cb-907be7571136

培养三天后的测试结果表明,浓度为1 mg/ml(药理学相关浓度)的Opaganib可完全抑制病毒复制。在RedHill研究中,这种有效的opaganib活性可完全与作为活性对照的rererestvir数据相媲美,该研究中的相关数据与发表的rererestvir数据一致3。 该项研究数据计划提交给经同行评议的期刊。

“Opaganib先前已证明具有抗炎活性,加上我们现已得到证实的特效抗SARS-CoV-2病毒活性,它可提供一种独特的双重作用机制,通过抑制疾病恶化的关键驱动因素——病毒复制和肺炎,有可能使新冠肺炎患者大大受益,”RedHill医疗总监、医学博士、理学博士Mark L. lelett指出。“采用与生理相关的人体呼吸组织模型获得的这些令人信服的数据表明,opaganib具有强烈抑制SARS-CoV-2病毒复制的潜力,证实了我们正在进行的全球2/3期和美国2期临床研究的基础假设,并为其基本理论依据提供了进一步支持。因此,我们正在朝着生成强大数据包以潜在支持新冠肺炎紧急使用授权的目标加速推进。” 

这项正在进行的全球多中心、随机、双盲、平行、安慰剂对照的2/3期研究 (NCT04467840),评估opaganib用于重症新冠肺炎患者的治疗,该项研究会继续招募多达270名需要住院和辅助供氧治疗的患者。该项研究最近在以色列获得批准,并且已经在英国、意大利、俄罗斯和墨西哥获得批准,进一步的扩展也在进行中。

与此同时,opaganib对重症新冠肺炎患者的随机、双盲、安慰剂控制的美国2期研究 (NCT04414618) 的受试率已超过50%,计划在未来几周内完成患者招募。最近,一家预先安排的独立安全监测委员会建议,该项研究应继续按原计划进行。该项研究并非以统计显著性为目标,计划招募40名需要住院和辅助供氧治疗的新冠肺炎患者。

RedHill正在围绕潜在的资金事项与美国政府机构进行讨论,以为迅速推进潜在的紧急使用opaganib批准提供支持。

除了opaganib外,RedHill的体外研究还评估了其2期试验药RHB-107 (upammostat) 的抗病毒活性,该药物是一种针对多种人类丝氨酸蛋白酶具有活性的丝氨酸蛋白酶抑制剂,研究结果证明可有效抑制SARS-CoV-2病毒复制。计划在今年晚些时候启动在门诊环境下针对RHB-107的美国2/3期研究。

“宿主细胞蛋白酶在SARS-CoV-2病毒进入细胞的过程中起着至关重要的作用,专门负责激活SARS-CoV-2纤突 (S) 蛋白,这是病毒进入期间病毒与宿主细胞膜融合的先决条件,” RedHill医疗总监、医学博士Terry F. Plasse解释说。“RHB-107表现出出色的抗病毒活性,可强烈抑制病毒复制,具有药理学相关浓度依赖性。与opaganib一样,RHB-107 (upammostat) 具有口服生物药效性,因此可能适合用于住院和门诊治疗。”

Opaganib和RHB-107的临床前研究结果仅为初步成果,由独立的第三方在进行初步独立分析后提供给RedHill公司,仍需对数据和潜在的支持性试验进行进一步的评审和分析。 

关于Opaganib (ABC294640, Yeliva®)
Opaganib是一种新的化学体,一种专有的首创口服鞘氨醇激酶-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、炎症和胃肠道适应症。

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。此外还有一项全球2/3期研究和一项美国2期研究正在对opaganib治疗新冠肺炎的效果进行评估。

临床前数据显示,opaganib同时具有抗炎和抗病毒活性,具有减少肺部炎性疾病(如肺炎)和减轻肺纤维化损害的潜力。Opaganib表现出对导致新冠肺炎SARS-CoV-2的有效抗病毒活性,在人体肺支气管组织的体外模型中完全抑制病毒复制。而且,临床前体内研究4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死亡率,并改善铜绿假细胞菌诱发的肺损伤。

opaganib最初由美国Apogee Biotechnology Corp开发,并在多项研究中获得成功,包括肿瘤、炎症、胃肠道和放射防护模型的多项临床前研究、针对晚期实体肿瘤患者的一项1期临床研究和一项额外的多发性骨髓瘤1期研究。

根据一项同情用药计划,以色列一家领先医院的新冠肺炎患者(按世界卫生组织的等级分类)接受了opaganib治疗。这些首批使用opaganib的新冠肺炎重症患者的治疗数据已经公布2。治疗结果分析表明,与同一医院回顾性配对病例对照组的患者相比,接受opaganib同情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%的患者需要使用呼吸机。opaganib治疗组的鼻高流量氧疗脱离的中位时间减少到10天,而匹配病例对照组则为15天。

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。

正在进行的各项opaganib研究已在www.ClinicalTrials.gov上注册,该网站是美国国家卫生研究院提供的一项网上服务,为公众提供了访问公共和私人支持的临床研究信息的途径。

关于RHB-107 (upamostat)
RHB-107是一种专有首创的针对几种丝氨酸蛋白酶的口服高效抑制剂,已证明具有抗病毒和潜在的组织保护功效。这种抗病毒和潜在组织保护的联合作用使其成为治疗新冠肺炎感染的有力候选药物。此外, RHB-107还具有治疗癌症、炎性肺部疾病和胃肠道疾病的潜力,已经进行了多项1期研究和两项2期研究,已经在300多名患者中证明了其临床安全性。RedHill从德国Heidelberg Pharmaceuticals(原名WILEX AG)获得了不包括中国、香港、台湾和澳门在内的全球RHB-107独家权利。

关于RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) 是一家专门致力于胃肠疾病治疗的专业生物制药公司。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)5Talicia®(用于治疗成人幽门螺旋杆菌 (H. pylori) 感染6Aemcolo®(用于治疗成人旅行时腹泻)7。RedHill的主要临床后期开发项目包括:(1) RHB-204,计划针对肺部非结核分枝杆菌 (NTM) 感染进行关键3期研究;(2) opaganib (Yeliva®),首创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的2期研究;(3) 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;(4) RHB-102 (Bekinda®),针对急性胃肠炎和胃炎的3期研究取得了积极成果,针对IBS-D的2期研究也取得了积极成果;(5) RHB-107,一款处于2期研究的首创丝氨酸蛋白酶抑制剂,针对癌症和炎性胃肠疾病,并且正在针对新冠肺炎进行评估;以及 (6) RHB-106,一种肠道准备胶囊。有关该公司的更多信息,请访问:www.redhillbio.com

Opaganib和RHB-107的临床前研究结果仅为初步成果,由独立的第三方在进行初步独立分析后提供给RedHill公司,仍需对数据和潜在的支持性试验进行进一步的评审和分析。此类评审和分析可能会出现与本新闻稿所披露结果不一致的发现,并且可能无法在未来的临床前或临床试验中复制。因此, 投资者不应依赖本新闻稿中所描述的结果作为opaganib对SARS-CoV-2抗病毒功效的权威证据,也不应依赖这些结果作为opaganib是否实际上将成为SARS-CoV-2有效疗法的权威证据。

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 Company’s Phase 2/3 study evaluating RHB-107 will not be successful, if conducted at all; the risk the antiviral activity in the in vitro study will not be demonstrated in clinical trials; the risk of a delay in receiving data to support applying for emergency use applications; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of enrollment for this clinical study will be delayed; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study in additional countries and that it will not be successful; the risk that the Company will not initiate the Phase 2/3 study in COVID-19 with RHB-107 or that it will be delayed;  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, Mexico or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; the risk of a delay in applying for emergency use authorizations; 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 compassionate use programs, as well as 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, 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 preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of Mycobacterium avium subspecies paratuberculosis (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, preclinical 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 events 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译文,为方便查阅目的而提供。

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
  

________________________________
1
Opaganib (Yeliva®, ABC294640) 是一种试验新药,尚未批准商业销售。
2 Na Zhu等. A Novel Coronavirus from Patients with Pneumonia in China, 2019(一种来自2019年中国肺炎患者的新型冠状病毒). N Engl J Med 2020;382:727-33.
3 Pruijssers AJ等. Remdesivir Inhibits SARS-CoV-2 in Human Lung Cells and Chimeric SARS-CoV Expressing the SARS-CoV-2 RNA Polymerase in Mice(瑞德西伟可抑制人体肺细胞中的SARS-CoV-2和小鼠中表达SARS-CoV-2 RNA聚合酶的嵌合体SARS-CoV)。Cell Reports. 32卷, 第3期, 107940, 2020年7月21日.
4 Xia C.等. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice(神经氨酸激酶的短暂抑制对感染甲型流感病毒的小鼠具有保护作用). Antiviral Res. 2018年10月; 158:171-177. Ebenezer DL等. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury(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.
5 Movantik® (naloxegol) 完整处方信息见: www.Movantik.com.
6 Talicia®(奥美拉唑镁、阿莫西林和利福布汀)的完整处方信息见: www.Talicia.com.
7 Aemcolo® (利福梅素)的完整处方信息见: www.Aemcolo.com.

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source: RedHill Biopharma Ltd.

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