Virios Therapeutics, Inc. Reaches Alignment With FDA on Requirements for Advancing Development Candidate IMC-2 as Treatment for Long-COVID
Virios Therapeutics, Inc. Reaches Alignment With FDA on Requirements for Advancing Development Candidate IMC-2 as Treatment for Long-COVID
ATLANTA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on developing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), today announced receipt of the Food and Drug Administration's ("FDA") feedback on requirements for advancing IMC-2 (combination of valacyclovir + celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC illness, also known as post-acute sequelae of SARS-CoV-2 infection ("PASC").
亞特蘭大，2024年1月2日（GLOBE NEWSWIRE）——Virios Therapeutics, Inc.（納斯達克股票代碼：VIRI）（“公司”）是一家處於開發階段的生物技術公司，專注於開發用於治療包括纖維肌痛（“FM”）和長冠狀病毒（“LC”）在內使人衰弱的慢性疾病的新型抗病毒療法，今天宣佈收到美國食品藥品監督管理局（“FDA”）關於推進要求的反饋 IMC-2（伐昔洛韋+塞來昔布的組合）可治療疲勞、體位不耐受和其他與 LC 疾病（也稱爲急性後期症狀）相關的症狀SARS-CoV-2 感染的後遺症（“PASC”）。
Key Highlights Associated with FDA Feedback
與 FDA 反饋相關的關鍵要點
The FDA agreed that for the planned Phase 2 proof-of-concept study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC.
The FDA recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths, to ensure effective inhibition of reactivated herpesvirus.
Following the receipt of the FDA's feedback, Virios is currently exploring options to advance the IMC-2 LC Phase 2 research program.
IMC-2 has the potential to be one of the first approved treatments specifically for LC.
美國食品藥品管理局同意，在計劃中的第二階段概念驗證研究中，Virios可以使用疲勞作爲主要終點，使用體位不耐受作爲關鍵的次要終點，來評估 IMC-2 治療PASC的有效性。
美國食品藥品管理局建議評估一系列 IMC-2 劑量，包括高於目前批准劑量的伐昔洛韋劑量，以確保有效抑制復活的皰疹病毒。
在收到美國食品藥品管理局的反饋後，Virios目前正在探索推進 IMC-2 LC 第二階段研究計劃的備選方案。
IMC-2 有可能成爲首批獲批准的專用於LC的治療方法之一。
"The National Service for Health Statistics estimates approximately 7% of US adults have had Long-COVID and strikingly, that 3.4% of adults currently have Long-COVID," said Greg Duncan, Chairman and CEO of Virios Therapeutics. "An Australian study found that 74% of the morbidity associated with SARS-COV-2 infection is associated with Long-COVID illness, further highlighting the need for new Long-COVID treatments," Duncan added.
Virios Therapeutics董事長兼首席執行官格雷格·鄧肯表示：“國家衛生統計局估計，大約7％的美國成年人患有長期COVID，引人注目的是，目前有3.4％的成年人患有長冠狀病毒。”鄧肯補充說：“澳大利亞的一項研究發現，與 SARS-COV-2 感染相關的發病率中有74％與長期COVID疾病有關，這進一步凸顯了對新的長期COVID治療的需求。”
About Virios Therapeutics
關於 Virios Therapeut
Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia ("FM") and Long-COVID ("LC"). Overactive immune response related to activation of tissue resident herpesvirus has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel syndrome, LC, chronic fatigue syndrome and functional somatic syndromes, all of which are characterized by a waxing and waning manifestation of disease, often triggered by events which compromise the immune system. Our lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dose combination of famciclovir and celecoxib) has been granted fast track designation by the FDA.
Virios Therapeutics（納斯達克股票代碼：VIRI）是一家處於開發階段的生物技術公司，專注於推進新型抗病毒療法，以治療與病毒引發的異常免疫反應相關的疾病，例如纖維肌痛（“FM”）和長冠狀病毒（“LC”）。據推測，與激活組織常駐皰疹病毒相關的免疫反應過度活躍是諸如FM、腸易激綜合症、LC、慢性疲勞綜合徵和功能性體細胞綜合徵等慢性病的潛在根本原因，所有這些疾病的特徵都是疾病的起伏和減弱表現，通常由損害免疫系統的事件引發。我們的先導開發候選藥物是抗病毒化合物和塞來昔布的新型、專有、固定劑量組合，旨在協同抑制皰疹病毒的複製，最終目標是減輕病毒促進的疾病症狀。IMC-1（泛昔洛韋和塞來昔布的固定劑量組合）已獲得美國食品藥品管理局的快速通道認證。
譯文內容由第三人軟體翻譯。