與歐洲和加拿大供應(yīng)商就opaganib的大規(guī)模增產(chǎn)進行合作進一步加強制造能力和產(chǎn)能，為潛在的緊急用藥申請獲批做好準(zhǔn)備
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使用opaganib治療新冠肺炎全球2/3期研究的患者招募在6個國家予以批準(zhǔn)后迅速推進
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在美國進行的opaganib治療新冠肺炎2期研究即將完成患者招募，并于最近通過了獨立委員會第二次審查

以色列特拉維夫和北卡羅來納羅利, Oct. 15, 2020 (GLOBE NEWSWIRE) -- 特種生物制藥企業(yè)RedHill Biopharma Ltd. （Nasdaq：RDHL）（以下稱“RedHill”或“公司”）今天宣布與歐洲和加拿大的兩家專業(yè)制藥廠商合作以推進opaganib的生產(chǎn)。針對這種新藥治療重癥新冠肺炎的全球范圍2/3期研究和在美國進行的2期研究正在快速進行中。此次宣布的生產(chǎn)合作旨在支持潛在的緊急用途申請及隨后的用藥需求。

“鑒于我們關(guān)于opagnib治療新冠肺炎2/3期研究開發(fā)計劃的快速推進，我們正在與倍受信賴的優(yōu)質(zhì)合作伙伴合作，擴大opaganib的制造能力和產(chǎn)能，以滿足全球緊急用藥申請一旦獲批后的用藥需求，”RedHill公司研發(fā)部高級副總裁Reza Fathi博士表示。

Opaganib是一種首創(chuàng)的口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，顯示抗炎和抗病毒雙重活性，靶向宿主細胞成分，因而有可能最大限度地降低耐藥可能性。

針對新冠肺炎重癥患者的opaganib后期開發(fā)項目包括：美國2期研究（NCT04414618），目前正在八個臨床試驗中心進行，患者招募已接近完成，并在最近通過了獨立委員會的第二次審查，預(yù)計數(shù)據(jù)將在今年年底前公布；全球2/3期研究（NCT04467840），正在15個研究地點迅速開展患者招募，有望在年底前招募270名患者。兩項研究均為將opaganib用于需住院治療和輔助供氧的新冠肺炎重癥患者的隨機、雙盲、平行、安慰劑對照型試驗。

Opaganib表現(xiàn)出對導(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。

該公司正在與美國政府機構(gòu)就可能提供的資金進行討論，以支持opaganib作為緊急用藥的潛在申請以及擴大生產(chǎn)規(guī)模方面取得的迅速進展。

關(guān)于Opaganib（ABC294640，Yeliva^?）
Opaganib作為一種新型化學(xué)實體，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，并有可能針對多種腫瘤、病毒、炎癥和腸道適應(yīng)癥。

opaganib獲得了美國FDA針對治療膽管癌的罕見病用藥批準(zhǔn)，目前正在進行晚期膽管癌2a期研究評估和前列腺癌2期研究評估。此外還有一項全球2/3期研究和一項美國2期研究正在對opaganib治療新冠肺炎的效果進行評估。

臨床前數(shù)據(jù)顯示，opaganib同時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¹表明，通過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Apogee Biotechnology Corp開發(fā)，并在多項研究中獲得成功，包括腫瘤、炎癥、胃腸道和放射防護模型的多項臨床前研究、針對晚期實體腫瘤患者的一項1期臨床研究和一項額外的多發(fā)性骨髓瘤1期研究。

根據(jù)一項同情用藥計劃，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)院回顧性配對病例對照組的患者相比，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)空氣且無需使用插管和呼吸機的情況下出院，而對應(yīng)的病例對照組中有33%的患者需要插管和使用呼吸機。opaganib治療組的鼻高流量氧療脫離的中位時間減少到10天，而匹配病例對照組則為15天。

Opaganib的開發(fā)因美國聯(lián)邦和州政府機構(gòu)給予Apogee Biotechnology Corp.的撥款和合同而得到支持，相關(guān)機構(gòu)包括NCI、BARDA、美國國防部和FDA罕見病藥物開發(fā)辦公室。

正在進行的各項opaganib研究已在www.ClinicalTrials.gov上注冊，該網(wǎng)站是美國國家衛(wèi)生研究院提供的一項網(wǎng)上服務(wù)，為公眾提供了訪問公共和私人支持的臨床研究信息的途徑。

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²、Talicia^?——用于治療成人幽門螺桿菌（H. pylori）³感染和Aemcolo^?——用于治療成人旅行者腹瀉⁴。RedHill的主要臨床后期開發(fā)項目包括：(1) RHB-204，計劃針對肺部非結(jié)核分枝桿菌 (NTM) 感染進行關(guān)鍵3期研究；(2) opaganib (Yeliva^?)，首創(chuàng)SK2選擇性抑制劑，針對多種適應(yīng)癥，正在進行新冠肺炎治療的2/3期研究，以及針對前列腺癌和膽管癌進行的2期研究；(3) RHB-104，針對克羅恩氏病進行的3期首次研究取得了積極成果；(4) RHB-102 (Bekinda^?)，針對急性胃腸炎和胃炎的3期研究取得了積極成果，針對IBS-D的2期研究也取得了積極成果；(5) RHB-107，一款處于2期研究的首創(chuàng)絲氨酸蛋白酶抑制劑，針對癌癥和炎性胃腸疾病，并且正在針對新冠肺炎進行評估；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，請訪問：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 of a delay in receiving data to support emergency use applications?or in making such emergency use applications, if at all; 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?and the data from this clinical study?will be delayed?if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful?and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; 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。

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1}?Xia 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感染甲型流感病毒小鼠的保護作用） 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。
²??Movantik^??（naloxegol）的完整處方信息請見：?www.Movantik.com。?
³?Talicia^??（奧美拉唑鎂、阿莫西林和利福布?。┑耐暾幏叫畔⒄堃姡?www.Talicia.com。 ? ? ?
⁴?Aemcolo^??（利福霉素）的完整處方信息請見：?www.Aemcolo.com。?