NanoViricides Ships NV-387 to DRC for Phase II MPox Trial

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 said 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 strain has been associated with higher morbidity and mortality, making the development of effective treatments a public health priority. NanoViricides noted that NV-387, a broad-spectrum antiviral candidate, has also been proposed for evaluation against Ebola virus infections, and the shipment makes the drug locally available should it be utilized in response efforts.

The significance of this development extends beyond MPox. NV-387 is the company’s lead drug candidate, designed as a broad-spectrum antiviral with potential applications against respiratory syncytial virus (RSV), COVID-19, long COVID, influenza, and other respiratory viral infections, as well as MPox/smallpox and even measles. NanoViricides believes that successful clinical development of NV-387 could position the therapy as a potential treatment option for multiple viral diseases, addressing significant unmet medical needs.

The DRC has been grappling with recurrent outbreaks of MPox, particularly the Clade I strain, which has a higher case fatality rate than the Clade II strain that caused the global outbreak in 2022. Currently, there are limited treatment options available, and the World Health Organization has emphasized the need for safe and effective therapies. If NV-387 proves effective, it could become a critical tool in outbreak control and patient management in endemic regions.

NanoViricides’ platform technology is based on the TheraCour nanomedicine technology, which the company licenses from TheraCour Pharma, Inc. NV-387 is a nanoviricide drug candidate that does not encapsulate remdesivir, unlike its other candidate NV-CoV-2-R, which encapsulates remdesivir. The company holds exclusive licenses for several viral diseases, including HIV/AIDS, hepatitis B and C, rabies, herpes, influenza, dengue, Japanese encephalitis, West Nile, Ebola/Marburg, and certain coronaviruses.

The broader implications of this trial are substantial. If NV-387 demonstrates safety and efficacy in MPox patients, it could pave the way for its use against other viral pathogens, including Ebola, which has also caused devastating outbreaks in the DRC and other African countries. The availability of a broad-spectrum antiviral could revolutionize outbreak response, reducing the need for multiple specific therapies and enabling rapid deployment against emerging viral threats.

However, the path to drug development is lengthy and capital-intensive, with no guarantee of success. NanoViricides acknowledges that there can be no assurance that NV-387 will show sufficient effectiveness and safety in human clinical trials. Nevertheless, the shipment of drug supply marks a tangible step forward in the fight against MPox and highlights the potential of broad-spectrum antivirals in global health security. For more information, visit https://ibn.fm/CTIZc.

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