NanoViricides Receives Regulatory Approval for Phase II MPox Treatment Trial in Democratic Republic of Congo

NanoViricides, Inc. has achieved a significant regulatory milestone with the Democratic Republic of Congo's regulatory agency ACOREP approving the start of a Phase II clinical trial evaluating NV-387 for the treatment of MPox caused by hMPXV infection. The trial will assess both safety and effectiveness of the experimental drug, pending final document submissions. This approval represents a crucial step forward in the development pathway for what could become a transformative antiviral therapy.

NV-387 represents a novel approach to antiviral treatment, designed to mimic human cells to trap and destroy viruses. The drug candidate has demonstrated potential as a broad-spectrum antiviral targeting up to 95% of human pathogenic viruses, according to company statements. The technology platform underlying NV-387 is based on intellectual property and proprietary know-how from TheraCour Pharma, Inc., with NanoViricides holding exclusive licenses for development in specific viral disease areas. The company's business model centers on licensing technology from TheraCour for specific application verticals of particular viruses, as established at its foundation in 2005.

The significance of this regulatory approval extends beyond MPox treatment alone. NV-387 is positioned as a broad-spectrum antiviral that the company plans to develop for multiple respiratory viral infections including RSV, COVID, Long COVID, and Influenza, in addition to MPOX/Smallpox infections. The potential impact of such a drug could be substantial, given the company's comparison to how antibiotics transformed bacterial disease treatment. If successful, this approach could provide a versatile therapeutic option against numerous viral threats, reducing dependence on virus-specific treatments.

NanoViricides operates as a clinical stage company creating special purpose nanomaterials for antiviral therapy, with its novel nanoviricide class of drug candidates representing a distinct technological approach. The company maintains a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections, though this agreement excludes cancer and similar diseases that may have viral origin but require different treatment approaches. Additional information about the company's technology and programs can be found at https://www.nanoviricides.com.

Beyond NV-387, NanoViricides is developing other advanced drug candidates including NV-HHV-1 for the treatment of Shingles, along with drugs targeting numerous other viral diseases such as oral and genital Herpes, viral eye diseases including EKC and herpes keratitis, various influenza strains, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. The company holds worldwide exclusive perpetual licenses for several drugs targeting specific viral diseases through its relationship with TheraCour, which licenses the underlying nanomedicine technology from AllExcel. The path to typical drug development remains extremely lengthy and requires substantial capital, with no assurance that any pharmaceutical candidates will show sufficient effectiveness and safety for successful clinical development.