InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination With Other Immunomodulators
InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination With Other Immunomodulators
JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego.
德國耶拿，2024年5月21日（GLOBE NEWSWIRE）——通過靶向補體系統開創抗炎療法的生物製藥公司InflarX N.V.（納斯達克股票代碼：IFRX）公佈了將於2024年5月17日至22日在聖地亞哥舉行的美國胸科學會（ATS）2024年國際會議上公佈的數據。
InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET. The poster is titled, "Vilobelimab in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients" and is being presented during the "ARDS and Acute Respiratory Failure: Mechanism, Risk, and Outcomes" thematic poster session.
InflarX將在今天太平洋時間上午11點30分/美國東部時間下午2點30分至太平洋時間下午1點15分/美國東部時間下午 4:15 的ATS會議的主題海報發佈會上展示海報。該海報的標題是 “維洛貝利單抗與託珠單抗或巴瑞替尼聯合使用可顯著提高危重 COVID-19 患者的死亡率”，並在 “急性呼吸衰竭和急性呼吸衰竭：機制、風險和結果” 主題海報發佈會上展出。
The data being presented is derived from a post-hoc subgroup analysis of the PANAMO Phase III global study, one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated (IMV) COVID-19 patients in intensive care units in adult critically ill COVID-19 patients. Tocilizumab, an anti-IL6R antibody, and baricitinib, a JAK inhibitor, are immunomodulators used in some patients as part of the standard of care treatment in this trial. PANAMO included a total of 369 patients and was used to support the emergency use authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) in April 2023 for GOHIBIC (vilobelimab) for the treatment of critically ill COVID-19 patients.
所提供的數據來自對PANAMO III期全球研究的事後亞組分析，該研究是最大的 1:1 隨機雙盲安慰劑對照試驗之一，對象是成人危重症監護室的侵入性機械通氣 (IMV) COVID-19 患者。COVID-19Tocilizumab（一種抗IL6R抗體）和巴瑞替尼（一種JAK抑制劑）是免疫調節劑，用於某些患者，作爲該試驗標準護理治療的一部分。PANAMO 共包括 369 名患者，用於支持美國食品藥品監督管理局 (FDA) 於 2023 年 4 月批准的 GOHIBIC (vilobelimab) 用於治療 COVID-19 危重患者的緊急使用授權 (EUA)。
The analysis presented at ATS 2024 is comprised of 71 patients from PANAMO that assessed 28- and 60-day all-cause mortality in the subgroup of patients taking the combination of vilobelimab plus tocilizumab or baricitinib versus patients on placebo plus tocilizumab or baricitinib. All patients received standard of care. Safety was also assessed.
在ATS 2024上發表的分析包括來自PANAMO的71名患者，他們評估了服用維洛貝利單抗加託珠單抗或巴瑞替尼組合的患者與服用安慰劑加託珠單抗或巴瑞替尼的患者相比的28天和60天全因死亡率。所有患者都接受了標準護理。還評估了安全性。
The point estimate for 28-day all-cause mortality was 6.3% in the vilobelimab plus tocilizumab or baricitinib arm, and 40.9% in the placebo plus tocilizumab or baricitinib arm: this is a significant relative reduction of 84.6% (HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms. Day 60 all-cause mortality was 16.4% and 49.3%, respectively (HR 0.25; 95% CI:0.09-0.68, p=0.006), a significant relative reduction.
據估計，維洛貝利單抗加託珠單抗或巴瑞替尼組28天全因死亡率爲6.3％，安慰劑加託珠單抗或巴瑞替尼組爲40.9％：這兩個組之間的相對顯著下降了84.6％（HR 0.13；95% CI：0.03-0.56，p=0.006）。第60天全因死亡率分別爲16.4％和49.3％（HR 0.25；95％置信區間：0.09-0.68，p=0.006），相對顯著下降。
The co-administration of vilobelimab with baricitinib or tocilizumab was not associated with safety concerns. In addition, demographics of these subgroups were generally well-balanced and comparable to the overall study population.
維洛貝利單抗與巴瑞替尼或託珠單抗的聯合給藥與安全問題無關。此外，這些亞組的人口結構總體上非常平衡，與總體研究人群相當。
Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: "I am thrilled that we can share this additional data from the PANAMO study, which will provide further scientific insights into the utility of vilobelimab when used with tocilizumab and baricitinib in critically ill hospitalized COVID-19 patients. We believe this analysis further supports the life-saving potential of vilobelimab in the acute care setting and indicates our continued commitment to these patients."
InflarX首席醫學官Camilla Chong醫學博士評論說：“我很高興我們能夠分享來自PANAMO研究的額外數據，這將爲維洛貝利單抗與託珠單抗和巴瑞替尼一起用於危重住院的 COVID-19 患者提供進一步的科學見解。我們認爲，這項分析進一步支持了維洛貝利單抗在急診環境中的救生潛力，並表明了我們對這些患者的持續承諾。”
About Vilobelimab
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum and cutaneous squamous cell carcinoma.
關於 Vilobelimab
Vilobelimab 是同類首創的單克隆抗人補體因子 c5a 抗體，可高度有效地阻斷 c5a 的生物活性，並對其在人體血液中的靶點表現出高度的選擇性。因此，作爲先天免疫系統的重要防禦機制，vilobelimab保持了膜攻擊複合物（c5b-9）的形成，而阻斷C5的分子則不是這樣。在臨床前研究中，vilobelimab已被證明可以通過特異性阻斷作爲該反應的關鍵 “放大器” 的c5a來控制炎症反應驅動的組織和器官損傷。除在 COVID-19 中開發外，vilobelimab 還正在開發用於各種使人衰弱或危及生命的炎症適應症，包括壞疽性膿皮病和皮膚鱗狀細胞癌。
Important Information about GOHIBIC (vilobelimab)
Vilobelimab has been granted an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or extracorporeal membrane oxygenation.
關於 GOHIBIC（維洛貝利單抗）的重要信息
如果在接受 IMV 或體外膜氧合後 48 小時內開始治療，維洛貝利單抗已獲得 EUA，用於治療住院成人 COVID-19。
The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.
GOHIBIC（vilobelimab）的緊急使用僅在根據該法案第 564 (b) (1) 條、21 U.S.C. § 360bbb-3 (b) (1) 條宣佈存在授權在 COVID-19 疫情期間緊急使用藥物和生物製品的情形的期間內才獲准緊急使用，除非聲明終止或更早撤銷授權。
Vilobelimab is an investigational drug that has not been approved by the FDA for any indication including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC (vilobelimab) website ().
維洛貝利單抗是一種研究藥物，尚未獲美國食品藥品管理局批准用於任何適應症，包括用於治療 COVID-19。關於使用GOHIBIC（維洛貝利單抗）治療 COVID-19 住院患者的安全性和有效性的已知信息有限。請在GOHIBIC（vilobelimab）網站上的《醫療保健提供者情況說明書》、《患者和家長/看護者情況說明書》和《美國食品藥品管理局授權書》（）中查看更多信息。
Important Safety Information about GOHIBIC (vilobelimab)
There is limited clinical data available for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab) use.
有關 GOHIBIC（vilobelimab）的重要安全信息
GOHIBIC（維洛貝利單抗）的可用臨床數據有限。使用GOHIBIC（維洛貝利單抗）可能會發生以前未報告的嚴重和意外不良事件（AE）。
GOHIBIC (vilobelimab) has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.
GOHIBIC（維洛貝利單抗）與嚴重感染的增加有關。對於 COVID-19 患者，在使用 GOHIBIC（維洛貝利單抗）治療期間和之後監測新感染的體徵和症狀。GOHIBIC（維洛貝利單抗）已觀察到超敏反應。如果發生嚴重的超敏反應，應停止給藥GOHIBIC（維洛貝利單抗），並開始適當的治療。
The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
最常見的不良反應（發生率 ≥ 3%）是肺炎、敗血症、神志失常、肺栓塞、高血壓、氣胸、深靜脈血栓形成、單純皰疹、腸球菌感染、支氣管肺麴黴病、肝酶升高、尿路感染、缺氧、血小板減少症、縱隔性肺炎、呼吸道感染、心室上感染心動過速、便秘和皮疹。
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths occurring during GOHIBIC (vilobelimab) treatment and considered to be potentially attributable to GOHIBIC (vilobelimab).
醫療保健提供者和/或其指定人員有責任強制要求FDA MedWatch報告在GOHIBIC（維洛貝利單抗）治療期間發生的、被認爲可能歸因於GOHIBIC（維洛貝利單抗）的所有用藥錯誤和嚴重不良反應或死亡。
Report side effects to the FDA at 1-800-FDA-1088 or . In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de
通過 1-800-FDA-1088 或... 向美國食品藥品管理局報告副作用。此外，副作用可以通過以下方式向 InflarX 報告：pvusa@inflarx.de
譯文內容由第三人軟體翻譯。