NanoViricides, Inc. (NYSE American: NNVC) announced that its Phase II clinical trial evaluating NV-387 Oral Gummies as a treatment for Bundibugyo Ebolavirus and other Ebola viruses has begun enrolling and dosing patients at an Ebola Treatment Center in the Ituri province of the Democratic Republic of Congo (DRC). The Phase IIA portion began enrollment and dosing around Sept. 23 and is designed to establish an NV-387 dosing protocol that is safe and well tolerated, with the resulting protocol to be used in the Phase IIB portion evaluating safety, tolerability and effectiveness. The trial is registered in the Pan African Clinical Trials Registry under identification number PACTR202608748555077.
This development is crucial because Ebola outbreaks, particularly those caused by the Bundibugyo strain, have historically had limited treatment options. The initiation of this trial represents a significant step toward a potential oral therapy that could be deployed in outbreak settings where intravenous administration is challenging. If successful, NV-387 could provide a much-needed broad-spectrum antiviral, not only for Ebola but also for other viral diseases including RSV, COVID-19, Influenza, and MPOX/Smallpox.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its novel nanoviricide(TM) class of drug candidates is based on intellectual property and technology from TheraCour Pharma, Inc. The company's lead drug candidate, NV-387, is being developed as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. Another advanced candidate is NV-HHV-1 for Shingles. The company's business model relies on licensing technology from TheraCour for specific viral applications, and it holds a worldwide exclusive perpetual license for several human viral diseases.
For investors, this trial's progress is a key indicator of the company's ability to advance its pipeline. The company's newsroom at https://ibn.fm/NNVC provides ongoing updates. The path to drug development is lengthy and requires substantial capital, and there can be no assurance that any candidates will show sufficient effectiveness and safety for human clinical development.
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