NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing antiviral drugs, has provided new details on its Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo Ebolavirus (BDBV) outbreak and other Ebola viruses in the Democratic Republic of Congo. According to the company, the trial is proceeding as designed, with enrollment in Phase IIA beginning on or about Sept. 23, 2026. Phase IIA is intended to identify an optimal, well-tolerated dosing regimen and serve as a go/no-go step before Phase IIB, a randomized controlled trial designed to evaluate efficacy. The progression to Phase II testing represents a critical milestone for a drug candidate that, if successful, could offer a new tool against a deadly virus.
NV-387 is designed to attack the virus and reduce viral load. It is delivered as an oral gummy that dissolves in the mouth without requiring water or swallowing effort. This mode of administration is particularly significant for outbreak response, as the company noted that, if successful, the oral treatment could be readily deployed in resource-limited settings. In regions where Ebola outbreaks occur, access to clean water and medical infrastructure can be limited, making a shelf-stable, orally dissolving formulation potentially transformative for treatment delivery.
NanoViricides characterized NV-387 as a broad-spectrum antiviral that mimics a host-side feature used by Ebola viruses and said there is a rationale for potential activity against Bundibugyo and other Ebola viruses. The ongoing outbreak in the DRC involves the Bundibugyo strain, for which treatment options are limited. Should NV-387 demonstrate safety and efficacy, it could provide a much-needed therapeutic option not only for this outbreak but also for future Ebola outbreaks.
The potential impact extends beyond Ebola. NanoViricides’ platform technology is based on the TheraCour® nanomedicine technology, and the company is developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The company’s lead drug candidate, NV-387, is also being planned for development as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections, and even Measles. The advancement of NV-387 into Phase II human clinical trials is therefore a key step for the company’s broader antiviral pipeline.
For investors and industry observers, the trial’s progression is a noteworthy event. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC. The company has stated that it cannot project an exact date for filing an Investigational New Drug application for any of its drugs because of dependence on a number of external collaborators and consultants, but it is currently focused on advancing NV-387 into Phase II human clinical trials. As is customary, the company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital, and there can be no assurance at this time that any of its pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development.
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