NanoViricides, Inc. (NYSE American: NNVC) announced that it has shipped NV-387 Oral Gummies to the Democratic Republic of Congo (DRC) in preparation for a Phase II clinical trial evaluating the drug as a treatment for MPox. The company stated that site preparations are being conducted by its contract research organization, Om Sai Clinical Research Pvt. Ltd., and local partners, with patient enrollment and dosing expected to begin following completion of staff training in the coming weeks.
The trial will assess the safety and effectiveness of NV-387 in patients with MPox caused by human monkeypox virus infection, primarily the more severe Clade I strain endemic to the DRC. This shipment makes the drug locally available should it be utilized in response efforts, and the company noted that NV-387 has been proposed for evaluation against Ebola virus infections. NanoViricides believes that successful clinical development of NV-387 could position the therapy as a potential treatment option for multiple viral diseases, including MPox and Ebola.
NV-387 is a broad-spectrum antiviral candidate and the company's lead drug candidate. It is also being developed for RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections. The company is focused on advancing NV-387 into Phase II human clinical trials. The press release is available at https://ibn.fm/CTIZc.
NanoViricides is a clinical stage company that creates special purpose nanomaterials for antiviral therapy. Its novel nanoviricide class of drug candidates and technology are based on intellectual property and proprietary know-how of TheraCour Pharma, Inc. The company has a Memorandum of Understanding with TheraCour for the development of drugs for all antiviral infections. The company's business model is based on licensing technology from TheraCour for specific application verticals of specific viruses.
In addition to NV-387, the company's other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. NanoViricides holds a worldwide exclusive perpetual license to TheraCour's nanomedicine technology for several drugs with specific targeting mechanisms.
The company cautions that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts, there can be no assurance that any of the company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance that successful results against coronavirus in the lab will lead to successful clinical trials or a successful pharmaceutical product.
