NanoViricides Has Received Approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo

Core Viewpoint - NanoViricides, Inc. has received approval from the regulatory agency ACOREP in the Democratic Republic of Congo to start Phase II clinical trials for NV-387, a broad-spectrum antiviral drug aimed at treating MPox disease caused by hMPXV infection [1][2]. Regulatory Approval - The Phase II clinical trial for NV-387 is cleared to proceed, contingent upon the filing of certain documents [2]. - The approval marks a significant milestone in the regulatory development of NV-387, as stated by the company's President and Executive Chairman, Anil R. Diwan [2]. Current Treatment Landscape - There are currently no effective drugs available for treating hMPXV infections that cause MPox disease. A clinical trial for tecovirimat (TPOXX®) failed to show effectiveness over placebo [3]. - Another drug, brincidofovir (TEMBEXA®), is undergoing a clinical trial called "MOSA," but its current status is unknown [3]. MPox Disease Context - MPox Clade II has become endemic in the USA, primarily affecting a limited population of men who have sex with men (MSM) due to transmission during sexual activity [4]. - Recent cases of MPox Clade I in California suggest potential community spread of the virus [5]. NV-387 Drug Profile - NV-387 is designed to mimic human cells, allowing it to trap and destroy viruses, targeting over 90-95% of human pathogenic viruses [6]. - The drug has shown high effectiveness in animal models against various viral infections, including influenza, RSV, and coronaviruses, surpassing existing treatments [10][11]. - NV-387 has demonstrated strong antiviral activity against orthopoxviruses, indicating potential effectiveness against MPox and Smallpox [12]. Development and Future Prospects - The company is compiling required documentation for the Clinical Trial Application, which will be submitted to ACOREP for patient recruitment approval [7][8]. - NV-387 is positioned as a revolutionary treatment for viral diseases, with the potential to address the limitations of current antiviral therapies [15][16]. Company Overview - NanoViricides, Inc. is a clinical-stage company focused on developing nanomaterials for antiviral therapy, with a lead drug candidate NV-387 targeting multiple viral infections, including MPox [17][20]. - The company has a licensing agreement with TheraCour Pharma for the development of antiviral drugs, holding exclusive rights to several technologies [19][22].