第二次計劃內(nèi)獨立安全監(jiān)測委員會（SMC）審查一致建議繼續(xù)按原方案進行opaganib治療新冠肺炎的美國2期研究
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美國2期研究已招募到75%的患者，數(shù)據(jù)
預計將在本季度末公布
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與此同時，opaganib治療新冠肺炎的全球2/3期研究的招募工作也進展迅速
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全球緊急使用授權申請已在計劃中，將等待積極臨床結果

以色列特拉維夫和北卡羅來納州羅利市, Oct. 09, 2020 (GLOBE NEWSWIRE) -- 特種生物制藥公司RedHill Biopharma Ltd.（納斯達克：RDHL ）（以下簡稱“ 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2期研究通過了獨立安全監(jiān)測委員會（SMC）的第二次計劃內(nèi)安全審查。委員會一致建議遵循原方案繼續(xù)進行研究。SMC的建議基于對研究中接受至少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2期研究（NCT04414618）正在八個臨床試驗中心進行，計劃在本月完成招募，預計數(shù)據(jù)將在今年年底前公布。2期研究不是為了驗證療效的效力，而是側重于安全評估和識別療效信號。

與此同時，opaganib針對重癥新冠肺炎患者的全球2/3期研究（NCT04467840）正在15個研究中心迅速展開招募，即將完成270例患者的招募目標。這項研究以療效評估為重點和目的。該項研究已在英國、意大利、俄羅斯、墨西哥、巴西和以色列獲得批準，目前正在進一步擴展。

“此次計劃內(nèi)第二次獨立安全審查涉及研究中60%患者的相關數(shù)據(jù)，審查的通過是當前進行的opaganib作為重癥新冠肺炎患者潛在治療藥物開發(fā)過程中的一個重要里程碑，”
RedHill醫(yī)療總監(jiān)Mark L. Levitt（醫(yī)學博士，哲學博士）說。
“我們正在快速建立有關opaganib的更多數(shù)據(jù)和經(jīng)驗，opaganib研究的安全性數(shù)據(jù)庫現(xiàn)已擁有近200例患者的數(shù)據(jù)。這給正在進行的全球2/3期研究提供了進一步支持。該研究的重點是確定療效，并有望在年底前招募270名患者?！?/p>

RedHill正在與美國政府機構就可能提供的資金進行討論，以支持opaganib為申請緊急用藥批準以及擴大生產(chǎn)規(guī)模而取得的迅速進展。

關于Opaganib（ABC294640，Yeliva^?）
Opaganib作為一種新型化學實體，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、炎癥和腸道適應癥。

opaganib獲得了美國FDA針對治療膽管癌的罕見病用藥批準，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治療重癥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病（如肺炎）和減輕肺纖維化損害的潛力。Opaganib表現(xiàn)出對導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制。此外，臨床前體內(nèi)研究²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果和炎癥標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)邦和州政府機構給予Apogee Biotechnology Corp.的撥款和合同而得到支持，相關機構包括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，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。 ?
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關于RedHill Biopharma???????????
RedHill Biopharma Ltd.（Nasdaq：RDHL) 是一家主要關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的主要臨床后期開發(fā)項目包括：(1) RHB-204，計劃針對肺部非結核分枝桿菌 (NTM) 感染進行關鍵3期研究；(2) opaganib (Yeliva^?)，首創(chuàng)SK2選擇性抑制劑，針對多種適應癥，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-107，一種處于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-106，一種腸道準備膠囊。有關該公司的更多信息，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?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是一種試驗性新藥，尚未批準商業(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。
³?3??Movantik^?（naloxegol）的完整處方信息請見：www.Movantik.com。
⁴?Talicia^?（奧美拉唑鎂、阿莫西林和利福布?。┑耐暾幏叫畔⒄堃姡簑ww.Talicia.com。 ??
⁵?Aemcolo^?（利福霉素）的完整處方信息請見：www.Aemcolo.com。