第二次計(jì)劃內(nèi)獨(dú)立安全監(jiān)測(cè)委員會(huì)（SMC）審查一致建議繼續(xù)按原方案進(jìn)行opaganib治療新冠肺炎的美國(guó)2期研究
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美國(guó)2期研究已招募到75%的患者，數(shù)據(jù)
預(yù)計(jì)將在本季度末公布
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與此同時(shí)，opaganib治療新冠肺炎的全球2/3期研究的招募工作也進(jìn)展迅速
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全球緊急使用授權(quán)申請(qǐng)已在計(jì)劃中，將等待積極臨床結(jié)果

以色列特拉維夫和北卡羅來(lái)納州羅利市, Oct. 09, 2020 (GLOBE NEWSWIRE) -- 特種生物制藥公司RedHill Biopharma Ltd.（納斯達(dá)克：RDHL ）（以下簡(jiǎn)稱“ RedHill”或“該公司”）今天宣布，該公司以opaganib（Yeliva?，ABC294640）¹治療重癥新冠肺炎住院患者的美國(guó)2期研究通過(guò)了獨(dú)立安全監(jiān)測(cè)委員會(huì)（SMC）的第二次計(jì)劃內(nèi)安全審查。委員會(huì)一致建議遵循原方案繼續(xù)進(jìn)行研究。SMC的建議基于對(duì)研究中接受至少7天治療的前24名患者安全數(shù)據(jù)的非盲態(tài)分析。研究已招募到75%的患者。

opaganib的美國(guó)2期研究（NCT04414618）正在八個(gè)臨床試驗(yàn)中心進(jìn)行，計(jì)劃在本月完成招募，預(yù)計(jì)數(shù)據(jù)將在今年年底前公布。2期研究不是為了驗(yàn)證療效的效力，而是側(cè)重于安全評(píng)估和識(shí)別療效信號(hào)。

與此同時(shí)，opaganib針對(duì)重癥新冠肺炎患者的全球2/3期研究（NCT04467840）正在15個(gè)研究中心迅速展開(kāi)招募，即將完成270例患者的招募目標(biāo)。這項(xiàng)研究以療效評(píng)估為重點(diǎn)和目的。該項(xiàng)研究已在英國(guó)、意大利、俄羅斯、墨西哥、巴西和以色列獲得批準(zhǔn)，目前正在進(jìn)一步擴(kuò)展。

“此次計(jì)劃內(nèi)第二次獨(dú)立安全審查涉及研究中60%患者的相關(guān)數(shù)據(jù)，審查的通過(guò)是當(dāng)前進(jìn)行的opaganib作為重癥新冠肺炎患者潛在治療藥物開(kāi)發(fā)過(guò)程中的一個(gè)重要里程碑，”
RedHill醫(yī)療總監(jiān)Mark L. Levitt（醫(yī)學(xué)博士，哲學(xué)博士）說(shuō)。
“我們正在快速建立有關(guān)opaganib的更多數(shù)據(jù)和經(jīng)驗(yàn)，opaganib研究的安全性數(shù)據(jù)庫(kù)現(xiàn)已擁有近200例患者的數(shù)據(jù)。這給正在進(jìn)行的全球2/3期研究提供了進(jìn)一步支持。該研究的重點(diǎn)是確定療效，并有望在年底前招募270名患者?！?/p>

RedHill正在與美國(guó)政府機(jī)構(gòu)就可能提供的資金進(jìn)行討論，以支持opaganib為申請(qǐng)緊急用藥批準(zhǔn)以及擴(kuò)大生產(chǎn)規(guī)模而取得的迅速進(jìn)展。

關(guān)于Opaganib（ABC294640，Yeliva^?）
Opaganib作為一種新型化學(xué)實(shí)體，是專有、首創(chuàng)口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，顯示抗炎和抗病毒雙重活性，靶向宿主細(xì)胞成分，有可能最大限度地降低病毒耐藥的可能性。Opaganib還顯示出抗癌活性，并有可能針對(duì)多種腫瘤、病毒、炎癥和腸道適應(yīng)癥。

opaganib獲得了美國(guó)FDA針對(duì)治療膽管癌的罕見(jiàn)病用藥批準(zhǔn)，目前正在進(jìn)行晚期膽管癌2a期研究評(píng)估和前列腺癌2期研究評(píng)估。此外還有一項(xiàng)全球2/3期研究和一項(xiàng)美國(guó)2期研究正在對(duì)opaganib治療重癥新冠肺炎的效果進(jìn)行評(píng)估。

臨床前數(shù)據(jù)顯示，opaganib同時(shí)具有抗炎和抗病毒活性，具有減少炎性肺部疾?。ㄈ绶窝祝┖蜏p輕肺纖維化損害的潛力。Opaganib表現(xiàn)出對(duì)導(dǎo)致新冠病毒的有效抗病毒活性，在人體肺支氣管組織的體外模型中完全抑制病毒復(fù)制。此外，臨床前體內(nèi)研究²表明，通過(guò)降低支氣管肺泡灌洗液中IL-6和TNF-α的水平，opaganib可降低流感病毒感染的病死率，并改善銅綠假單胞菌誘發(fā)的肺損傷。

opaganib最初由美國(guó)Apogee Biotechnology Corp開(kāi)發(fā)，并在多項(xiàng)研究中獲得成功，包括腫瘤、炎癥、胃腸道和放射防護(hù)模型的多項(xiàng)臨床前研究、針對(duì)晚期實(shí)體腫瘤患者的一項(xiàng)1期臨床研究和一項(xiàng)額外的多發(fā)性骨髓瘤1期研究。

根據(jù)一項(xiàng)同情用藥計(jì)劃，以色列一家領(lǐng)先醫(yī)院的新冠肺炎患者（按世界衛(wèi)生組織的等級(jí)分類）接受了opaganib治療。這些首批使用opaganib的新冠肺炎重癥患者的治療數(shù)據(jù)已經(jīng)公布²。治療結(jié)果分析表明，與同一醫(yī)院回顧性配對(duì)病例對(duì)照組的患者相比，接受opaganib同情用藥治療的患者在臨床結(jié)果和炎癥標(biāo)志物方面均有顯著獲益。opaganib治療組的所有患者都在呼吸室內(nèi)空氣且無(wú)需使用插管和呼吸機(jī)的情況下出院，而對(duì)應(yīng)的病例對(duì)照組中有33%的患者需要插管和使用呼吸機(jī)。opaganib治療組的鼻高流量氧療脫離的中位時(shí)間減少到10天，而匹配病例對(duì)照組則為15天。

Opaganib的開(kāi)發(fā)因美國(guó)聯(lián)邦和州政府機(jī)構(gòu)給予Apogee Biotechnology Corp.的撥款和合同而得到支持，相關(guān)機(jī)構(gòu)包括NCI、BARDA、美國(guó)國(guó)防部和FDA罕見(jiàn)病藥物開(kāi)發(fā)辦公室。

正在進(jìn)行的各項(xiàng)opaganib研究已在www.ClinicalTrials.gov上注冊(cè)，該網(wǎng)站是美國(guó)國(guó)家衛(wèi)生研究院提供的一項(xiàng)網(wǎng)上服務(wù)，為公眾提供了訪問(wèn)公共和私人支持的臨床研究信息的途徑。 ?
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關(guān)于RedHill Biopharma???????????
RedHill Biopharma Ltd.（Nasdaq：RDHL) 是一家主要關(guān)注腸胃疾病治療的特種生物制藥企業(yè)。RedHill目前推廣的胃腸藥物包括：Movantik^?——用于治療阿片類藥物引起的成人便秘³、Talicia^?——用于治療成人幽門螺桿菌（H. pylori）⁴感染和Aemcolo^?——用于治療成人旅行者腹瀉⁵。RedHill的主要臨床后期開(kāi)發(fā)項(xiàng)目包括：(1) RHB-204，計(jì)劃針對(duì)肺部非結(jié)核分枝桿菌 (NTM) 感染進(jìn)行關(guān)鍵3期研究；(2) opaganib (Yeliva^?)，首創(chuàng)SK2選擇性抑制劑，針對(duì)多種適應(yīng)癥，正在進(jìn)行新冠肺炎治療的2/3期研究，以及針對(duì)前列腺癌和膽管癌進(jìn)行的2期研究；(3) RHB-104，針對(duì)克羅恩氏病進(jìn)行的3期首次研究取得了積極成果；(4) RHB-102 (Bekinda^?)，針對(duì)急性胃腸炎和胃炎的3期研究取得了積極成果，針對(duì)IBS-D的2期研究也取得了積極成果；(5) RHB-107，一種處于2期研究的首創(chuàng)絲氨酸蛋白酶抑制劑，針對(duì)癌癥和炎性胃腸疾病，并且正在針對(duì)新冠肺炎進(jìn)行評(píng)估；以及 (6) RHB-106，一種腸道準(zhǔn)備膠囊。有關(guān)該公司的更多信息，請(qǐng)?jiān)L問(wèn)：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 Company’s Phase 2/3 study evaluating?opaganib?will not be successful; the risk?that?the antiviral activity?of opaganib shown?in?the?preclinical?human lung cell model?will not be demonstrated in clinical trials; the risk of a delay in receiving data to support emergency use applications; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in?Brazil,?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, if at all; 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 (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：本新聞稿是公司以英文發(fā)布的官方新聞稿的譯文，為方便查閱之目的而提供。

¹Opaganib是一種試驗(yàn)性新藥，尚未批準(zhǔn)商業(yè)銷售。
²Xia C.等。 Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice（神經(jīng)氨酸激酶的短暫抑制對(duì)感染甲型流感病毒小鼠的保護(hù)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（銅綠假單胞菌可刺激細(xì)胞核鞘糖苷-1-磷酸的生成和肺炎癥損傷的表觀遺傳調(diào)控） Thorax。2019年6月；74(6):579-591。
³?3??Movantik^?（naloxegol）的完整處方信息請(qǐng)見(jiàn)：www.Movantik.com。
⁴?Talicia^?（奧美拉唑鎂、阿莫西林和利福布汀）的完整處方信息請(qǐng)見(jiàn)：www.Talicia.com。 ??
⁵?Aemcolo^?（利福霉素）的完整處方信息請(qǐng)見(jiàn)：www.Aemcolo.com。