RedHill Biopharma 的 Opaganib 獲賓夕法尼亞州頒發 COVID-19 資助金

一項涉及多達 270 名嚴重 COVID-19 肺病住院患者的全球第 2/3 期研究，以及一項涉及多達 40 名患者的美國第 2 期研究，目前正在使用 opaganib。它是一種新型、口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，具有雙重抗炎和抗病毒特性Opaganib 已從賓夕法尼亞的 COVID-19 疫苗、治療和治療計劃中獲得資助，該計劃支持前景明朗的新型 COVID-19 療法快速發展以色列特拉維夫和紐約市拉里, Sept. 08, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd.（納斯達克：RDHL）（「RedHill」或「公司」）是一家專業生物製藥公司，今天宣佈選擇 opaganib¹，一種專利、一流、口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，現正評估其用於治療嚴重 COVID-19 肺炎的藥效，並從賓夕法尼亞州的 COVID-19 疫苗、治療及療法 (CV-VTT) 計劃中獲得 30 萬美元的資助，而該計劃旨在支持新型 COVID-19 療法快速發展而設計。此撥款已授予 RedHill 的合作夥伴 Apogee Biotechnology Corporation，而 RedHill 從中獲得 opaganib 授權，並將進行獲得資助的研究。RedHill 高級副總裁 Reza Fathi 博士說：「我們很高興賓夕法尼亞州認同我們第 2/3 階段候選藥物 opaganib 作為 COVID-19 患者急需治療選擇的潛力。 此項資助將有助於加速和擴展 opaganib 的發展，從而實現我們透過產生可靠數據潛在支援 COVID-19 緊急使用應用程式的目標。」來自賓夕法尼亞州的 CV-VTT 資助將涵蓋關鍵的臨床前機制研究，進一步驗證 opaganib 在抑制與 COVID-19 相關急性呼吸窘迫綜合徵 (ARDS) 相關的程度及/或持續時間的潛在作用。迄今為止，全球第 2/3 期評估 opaganib 用於治療 COVID-19 的研究已在英國、意大利、俄羅斯和墨西哥獲得批准，並持續納入患者及計劃進一步擴充。這項多中心、隨機、雙盲、平行組、安慰劑對照的第 2/3 期研究 (NCT04467840) 旨在納入多達 270 名需要住院和補充氧氣治療的嚴重 COVID-19 肺炎患者。Opaganib 的美國第 2 期臨床研究與全球第 2/3 期研究並行進行，目前參加者已超過 50%，並在未來幾週內完成納入程序。最近，預先安排的獨立安全監測委員會建議研究繼續進行，無需作出任何變化。當 24 名患者完成至少 7 天的治療後，下一次排定的 SMC 審查將隨之進行。這項研究並無統計學意義，是一項隨機、雙盲、安慰劑對照研究 (NCT04414618)，旨在納入多達 40 名需要住院治療和補充氧氣的嚴重 COVID-19 肺炎患者。關於Opaganib (ABC294640, Yeliva^®)
Opaganib 是新的化學實體，是一種專利的頂級口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，適應症為抗癌、抗炎和抗病毒活性，及針對多種腫瘤、病毒、發炎和腸胃問題。透過抑制 SK2，opaganib 可影響與癌症生長、病毒複製和病理發炎相關的多種細胞途徑。Opaganib 原本由總部位於美國的 Apogee Biotechnology Corp. 開發，至今已完成多項成功的臨床前研究，當中涉及腫瘤學、發炎、腸胃道和放射防護模型，以及針對患有晚期實體腫瘤癌症患者的第 1 期臨床研究。Opaganib 獲得美國 FDA 用於治療膽管癌的孤兒藥稱號，目前正在晚期膽管癌的第 2 期研究和前列腺癌第 2 期研究中接受評估。Opaganib 現在也被評估在第 2/3 期研究中用於治療冠狀病毒 (COVID-19)。最近宣佈經已發佈將 opaganib 用於治療嚴重 COVID-19 患者的治療結果²。對 5 名嚴重 COVID-19 患者的治療結果進行的分析表示，與同一醫院的回顧性配對病例對照組相比，在恩慈使用 opaganib 治療的患者中，臨床結果和發炎標記均獲得實益。Opaganib 治療組的所有患者均無需機械呼吸即可出院，而匹配病例對照組的 33% 則需要機械呼吸。在 opaganib 治療組中，從高流量鼻導管戒斷的中位時間減少至 10 天，而配對病例對照組則為 15 天。臨床前數據表示，opaganib 具有抗炎和抗病毒活性，並具有減輕肺部發炎疾病（如肺炎）和減輕肺纖維化損害的潛力。早前的一些臨床前研究支持 SK2 在類似冠狀病毒的正向單鏈 RNA 病毒的複制轉錄複合物中的潛在作用，而其抑制作用可能可抑制病毒複製。臨床前的體內研究² 已顯示 opaganib 透過降低支氣管肺泡灌洗液中的 IL-6 及 TNF-alpha 水平，成功降低流感病毒感染的死亡率，同時改善銅綠假單胞菌 (Pseudomonas aeruginosa) 誘導的肺損傷。Opaganib 的開發已獲得美國聯邦和州政府機構授予 Apogee Biotechnology Corp. 的贈款和合約支持，其中包括 NCI、BARDA、美國國防部和 FDA 孤兒藥品開發辦公室。關於 RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) 是一家專門生物製藥公司，專注於腸胃道疾病。 RedHill 推廣腸胃道藥物 Movantik^® 用於治療成人阿片類藥物引起的便秘³, Talicia^® 用於治療成人幽門螺桿菌 Helicobacter pylori (H. pylori) 感染⁴ 及 Aemcolo^® 用於治療成人旅遊人士的腹瀉問題⁵。RedHill 的關鍵臨床後期開發計劃包括：(i) RHB-204，當中計劃進行關鍵第 3 期肺炎非結核分枝桿菌 (NTM) 感染；(ii) opaganib (Yeliva^®)，這是針對多種適應症的一流 SK2 選擇性抑制劑，涉及針對 COVID-19 的第 2/3 期計劃及針對前列腺癌和膽管癌正在進行中的第 2 期研究；(iii) RHB-104，當中克隆氏症的首個第 3 期研究獲得正面結果；(iv) RHB-102 (Bekinda^®)，當中在急性腸胃炎和胃炎的第 3 期研究中獲得正面結果，及在 IBS-D 的第 2 期研究中獲得正面結果；(v) RHB–106，這是一種膠囊大腸制劑，以及 (vi) RHB-107，這是第 2 期一流的絲氨酸蛋白酶抑制劑，針對癌症和腸胃發炎，目前也接受 COVID-19 的評估。如欲了解更多關於公司的資訊，請瀏覽 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 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 in certain geographies, will not expand this study in additional countries and that it will not be successful; 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 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：為方便讀者，本新聞稿為公司發佈的英文新聞稿的翻譯版本。
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¹ Opaganib (Yeliva^®, ABC294640) is an investigational new drug, not available for commercial distribution.
² Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
³ 有關 Movantik^® (naloxegol) 的完整處方資訊載於：www.Movantik.com。
⁴ 有關 Talicia^® (omeprazole magnesium、amoxicillin 和 rifabutin) 的完整處方資訊載於：www.Talicia.com。
⁵ 有關 Aemcolo^® (rifamycin) 的完整處方資訊載於：www.Aemcolo.com。