NanoViricides Advances NV-387 Toward Phase II Trials for MPox and Pursues Orphan Drug Designations

NanoViricides, Inc. (NYSE American: NNVC) announced the filing of its quarterly report for the period ended March 31, 2026, detailing advancements in the development of its broad-spectrum antiviral candidate NV-387. The company has obtained regulatory approval to proceed with Phase II clinical development for MPox in the Democratic Republic of Congo, marking a significant milestone in its clinical pipeline.

In addition to the MPox trial progress, NanoViricides highlighted its orphan-first regulatory strategy, which has already secured FDA orphan drug designation for measles. The company has also submitted additional applications targeting MPox and smallpox, underscoring its commitment to addressing high-need infectious diseases with limited treatment options.

NV-387 is the lead drug candidate in NanoViricides' portfolio, designed as a broad-spectrum antiviral with potential applications against respiratory syncytial virus (RSV), COVID-19, long COVID, influenza, MPox, smallpox, and measles. The company plans to develop NV-387 for these indications, leveraging its proprietary nanoviricide technology platform.

The nanoviricide technology, based on intellectual property licensed from TheraCour Pharma, Inc., involves creating special purpose nanomaterials that mimic host cell receptors to bind and neutralize viruses. This approach aims to provide a versatile antiviral therapy effective against multiple viral pathogens.

NanoViricides also outlined its ongoing development of other drug candidates, including NV-HHV-1 for shingles and two COVID-19 candidates: NV-CoV-2 (API NV-387) and NV-CoV-2-R, which encapsulates remdesivir within polymeric micelles. The company believes that NV-CoV-2-R, leveraging the FDA-approved status of remdesivir, could follow an expedited regulatory pathway if safety is comparable.

The company's pipeline extends to a range of viral diseases, including oral and genital herpes, viral eye diseases, influenza strains, HIV, hepatitis C, rabies, dengue fever, and Ebola. NanoViricides holds exclusive licenses to TheraCour's nanomedicine technology for multiple human viral diseases, providing a broad foundation for future drug development.

Despite these advancements, NanoViricides acknowledges the inherent risks in pharmaceutical development. The path to market for any drug candidate is lengthy and capital-intensive, with no guarantee of clinical success or regulatory approval. The company cautions that laboratory results may not translate to successful clinical trials or commercial products.

For more information on NanoViricides and its latest updates, visit the company's newsroom at https://ibn.fm/NNVC.

The full press release is available at https://ibn.fm/osO0q.