NanoViricides Receives Orphan Drug Designation for NV-387 to Treat Measles Amid Rising Global Outbreaks

NanoViricides, Inc. (NYSE American: NNVC) announced today that its clinical-stage antiviral drug candidate NV-387 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of measles. The designation provides potential incentives including tax credits, fee exemptions, and market exclusivity, which could accelerate the drug's development and regulatory pathway. The company highlighted that NV-387 is a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles and is being developed to address rising global outbreaks of the highly contagious disease.

According to the press release, the Orphan Drug Designation supports the regulatory advancement of NV-387, which has already successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials. The drug candidate is also being developed as a treatment for respiratory syncytial virus (RSV), COVID-19, Long COVID, influenza, and other respiratory viral infections, and has shown effectiveness in animal models for monkeypox (MPox), smallpox, and measles.

The decision by the FDA underscores the urgent need for effective treatments against measles, which has seen a resurgence globally due to declining vaccination rates. The World Health Organization has reported a significant increase in measles cases worldwide, highlighting the importance of developing antiviral therapies as a complementary strategy to vaccination. NanoViricides' NV-387, with its broad-spectrum mechanism, could offer a novel approach to treating measles and other viral infections.

NanoViricides is a clinical-stage company that creates special purpose nanomaterials for antiviral therapy. The company's lead drug candidate is NV-387, a broad-spectrum antiviral that targets a range of respiratory viral infections. Another advanced candidate is NV-HHV-1 for the treatment of herpesvirus infections, including HSV-1 (cold sores), HSV-2 (genital ulcers), VZV (shingles), and chickenpox. The company noted that it cannot project an exact date for filing an Investigational New Drug (IND) application for any of its drugs due to dependence on external collaborators and consultants.

For more information about NanoViricides, visit the company's newsroom for the latest updates. The Orphan Drug Designation marks a significant milestone for NanoViricides as it seeks to address critical unmet medical needs in infectious diseases.