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NanoViricides Considers NV-387 for MPOX Treatment Under WHO Protocol Amid Global Outbreak

NanoViricides Considers NV-387 for MPOX Treatment Under WHO Protocol Amid Global Outbreak

全球爆發期間,NanoViricides考慮在世界衛生組織協議下使用NV-387治療MPOX
Benzinga ·  08/26 19:39

NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it is investigating the possibility of using NV-387 for the treatment of MPOX patients under the WHO MEURI protocol, in light of the recent WHO PHEIC (Public Health Emergency of International Concern) declaration for the current 2024 MPOX outbreak that is rapidly spreading into more than ten countries in Africa with additional cases detected in Thailand and Sweden.

納米病毒公司(NanoViricides, Inc.,NYSE:NNVC)是一家臨床階段全球領先的廣譜抗病毒納米藥公司,報告稱正在調查在世界衛生組織(WHO)MEURI協議下使用NV-387治療MPOX患者的可能性,鑑於最近WHO宣佈當前2024年MPOX疫情爲公共衛生緊急事件(PHEIC)並迅速在非洲十多個國家蔓延,同時在泰國和瑞典發現其他病例。

MEURI, i.e. Monitored Emergency Use of Unregistered and Investigational Interventions, is an ethical protocol developed by the World Health Organization to evaluate the potential use of experimental drugs in the event of public health emergencies ().

MEURI,即未經批准或試驗的監測緊急用途,是世界衛生組織開發的一種道德協議,旨在評估實驗性藥物在公共衛生緊急情況下的潛在用途。

The Company believes that the MEURI protocol may be applicable for the evaluation of NV-387 for the treatment of MPOX infection in patients. NV-387 has completed Phase I clinical trial for safety and tolerability studies in healthy subjects with no adverse events reported indicating excellent safety and tolerability. NV-387 has demonstrated strong improvement in survival in animal model studies matching that of the currently approved drug, tecovirimat, indicating excellent effectiveness. MPOX Clade 1/1b require development of new therapeutics due to limitations of existing therapies.

公司認爲MEURI協議可能適用於評估NV-387治療MPOX感染患者。NV-387已經完成了針對健康受試者的安全和耐受性研究的I期臨床試驗,未報告出現不良事件,表明其具有良好的安全性和耐受性。NV-387在動物模型研究中已經證明在生存率方面取得了顯著改善,與目前批准的藥物tecovirimat相當,表明其具有優異的療效。MPOX Clade 10/10億需要開發新的治療方法,因爲現有療法存在一定的侷限性。

Survival Lifespan of Lethally Infected Mice - Intradigital Skin Footpad Infection with Ectromelia Virus (Model for MPOX, Smallpox)
Treatment Survival, Days Increase in Survival, Days Increase in Survival, %
NV-387, Oral 14 6 75%
Tecovirimat, Oral 14 6 75%
NV-387-m-T, Oral 17 9 112.5%
Vehicle 8 0 0%
致命感染小鼠的存活壽命-皮膚足底數字化感染(模擬MPOX,天花)
治療 生存天數 存活天數變多 存活率提高
NV-387口服 14 6 75%
口服Tecovirimat 14 6 75%
此外,公司還發現NV-387在非臨床動物試驗中對三類重要呼吸病毒(RSV、流感和COVID)具有優越性或與現有藥物相當。這些所謂的「三重流行」呼吸病毒。公司認爲,當NV-387的有效性在人體臨床試驗中得到證實時,作爲一種能夠治療大量病毒的單一廣譜抗病毒藥物,可能在治療病毒感染方面具有像青黴素對細菌感染的革命性。 17 9 112.5%
汽車 8 0 0%

Additionally, the Company has also found that NV-387 was superior to or equivalent to existing drugs in non-clinical animal trials in the case of three major classes of respiratory viruses: RSV, Influenza, and COVID; the so-called "triple-demic" respiratory viruses. The Company believes that NV-387, as a single broad-spectrum antiviral drug that can treat a large number of viruses, could be as revolutionary for the treatment of viral infections as penicillin was to bacterial infections, when its effectiveness is proven in human clinical trials.

譯文內容由第三人軟體翻譯。


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