第二次排定的獨立安全監測委員會 (SMC) 審查一致建議不改變使用 opaganib 治療 COVID-19 的美國第 2 期研究
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美國第 2 期研究已納入 75% 的患者，預計本季度稍後將公佈數據
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與此同時，使用 opaganib 治療 COVID-19 的全球 2/3 期研究納入率迅速提高
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計劃進行全球緊急使用授權申請，但須取得積極的臨床結果
以色列特拉維夫和北卡羅萊納州拉里格, Oct. 09, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL)(「RedHill」或「公司」) 是專門生物製藥公司，今天宣佈，其用於嚴重 COVID-19 肺炎住院患者的 opaganib (Yeliva®, ABC294640)1 的美國第 2 期研究已成功通過第二次排定的獨立安全監測委員會 (SMC) 審查。SMC 的建議基於對在研究中治療至少 7 天的前 24 名患者的安全性數據進行的解盲分析。這項研究納入了 75% 的患者。
使用 opaganib (NCT04414618) 進行的美國第 2 期研究在 8 個臨床試驗地點進行，計劃於本月完成納入程序，預計於今年年底前公佈數據。第 2 期研究不為療效提供支持，並專注於安全評估及識別療效訊號。
與此同時，opaganib 用於嚴重 COVID-19 肺炎患者的全球第 2/3 期研究 (NCT04467840) 正在 15 個研究中心迅速啟動納入程序，將按預期納入多達 270 名患者。該研究專注於療效，並將為其提供支持。該研究已在英國、意大利、俄羅斯、墨西哥、巴西及以色列獲得批准，並進一步擴展。
RedHill 醫學總監 Mark L. Levitt
醫學博士說：「通過第二次排定的獨立安全審查，涉及研究中 60% 患者的數據，是 opaganib 作為嚴重 COVID-19 患者潛在治療方法的持續發展的重要里程碑。 Opaganib 研究的安全資料庫現已有接近 200 名患者的資料，我們正在快速建立更多 opaganib 數據和經驗。這進一步支持正在進行的全球第 2/3 期研究，該研究專注於療效，並有望在今年年底前納入多達 270 名患者。」
RedHill 正在與美國政府機構討論潛在資金，以支持 opaganib 快速促進潛在的緊急使用批准及加大生產規模。
關於 Opaganib (ABC294640, Yeliva®)
Opaganib 是全新的化學實體，是一種專有、一流的口服鞘氨醇激酶-2 (SK2) 選擇性抑制劑，展示出抗炎及抗病毒活性雙重作用，可針對宿主細胞成分，有可能盡量降低抗藥性的可能性。Opaganib 也表現出抗癌活性，並有可能針對多種腫瘤學、病毒、發炎及腸胃疾病。
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 目前正在全球第 2/3 期及美國第 2 期研究中接受用於治療嚴重 COVID-19 患者的評估。
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。Opaganib 對 SARS-CoV-2 表現出有效的抗病毒活性，該病毒導致 COVID-19，在人類肺支氣管組織體外模型中完全抑制病毒複製。 此外，臨床前的體內研究2已顯示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 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，以及另一項第 1 期的多發性骨髓瘤研究。
在一項恩慈使用計劃下，以色列一所領先醫院使用 opaganib 治療 COVID-19 患者（根據世衛序號量表分類）。最近宣佈經已發佈將 opaganib 用於治療嚴重 COVID-19 患者的治療數據2。治療結果的分析顯示，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 治療組的所有自主呼吸患者均無需插喉或機械呼吸即可出院，而匹配病例對照組的 33% 則需要插喉或機械呼吸。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。
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。
Opaganib 的持續研究在 www.ClinicalTrials.gov 註冊，這是美國國家衛生研究院的網上服務，為公眾提供有關公開和私人支持的臨床研究資訊。
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-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 的評估以及 (vi) RHB-106，這是一種膠囊大腸制劑。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 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：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。
| 公司聯絡人： Adi Frish 業務開發和許可高級副總裁 RedHill Biopharma +972-54-6543-112 adi@redhillbio.com | 投資者關係（美國）： Timothy McCarthy, CFA, MBA 常務董事，客戶關係經理 LifeSci Advisors, LLC +1-212-915-2564 tim@lifesciadvisors.com |
1 Opaganib 是一種試驗性新藥，尚未有商業分銷。
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。