NanoViricides, Inc. (NYSE American: NNVC) announced 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. This designation provides potential incentives including tax credits, fee exemptions, and market exclusivity, which can significantly support the drug's development and regulatory pathway.
NV-387 is a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles. The company is developing NV-387 to address the rising global outbreaks of measles, a highly contagious viral disease that can lead to serious complications and death, especially in children. The Orphan Drug Designation acknowledges the potential of NV-387 to fill a critical unmet medical need in the treatment of measles.
According to the press release, the company said the designation supports regulatory advancement of NV-387. This designation is part of a strategy to expedite the development of drugs for rare diseases or conditions that affect fewer than 200,000 people in the United States. Measles, while preventable through vaccination, continues to cause outbreaks worldwide due to gaps in vaccination coverage, making the need for effective treatments more urgent.
NanoViricides is a clinical stage company that creates special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is a unique broad-spectrum antiviral that the company plans to develop as a treatment for RSV, COVID-19, Long COVID, influenza, and other respiratory viral infections. Beyond measles, NV-387 has also shown effectiveness in animal models for monkeypox (MPox) and smallpox.
NV-387 has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. The company is currently focused on advancing NV-387 into Phase II human clinical trials. The Orphan Drug Designation may help facilitate this process by providing regulatory support and financial incentives.
In addition to NV-387, NanoViricides is developing NV-HHV-1 for the treatment of all herpesvirus infections, including HSV-1 (cold sores), HSV-2 (genital ulcers), VZV (shingles), and chickenpox. However, the company 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.
The latest news and updates relating to NanoViricides are available in the company’s newsroom at https://ibn.fm/NNVC. For more information about NanoViricides, visit the company's website at www.nanoviricides.com.
The Orphan Drug Designation for NV-387 marks a significant milestone for NanoViricides and underscores the potential of broad-spectrum antivirals in addressing emerging viral threats. As global measles outbreaks continue to rise, the development of effective treatments remains a public health priority.
