NanoViricides, Inc. (NYSE American: NNVC) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its clinical-stage antiviral drug NV-387 for the treatment of measles. This designation provides potential incentives including tax credits, fee exemptions, and seven years of market exclusivity upon approval, supporting the regulatory advancement of a candidate that has demonstrated in vivo activity against the virus.
The designation comes at a critical time as measles outbreaks are increasing globally, driven by declining vaccination rates. According to the World Health Organization, measles cases surged by 79% in 2022 compared to the previous year, underscoring the urgent need for effective treatments. NV-387 is a broad-spectrum antiviral that the company plans to develop for respiratory syncytial virus (RSV), COVID-19, Long COVID, influenza, and other respiratory viral infections. It has also shown efficacy in animal models for monkeypox (MPox), smallpox, and measles.
“Receiving Orphan Drug Designation for NV-387 in measles is a significant milestone that acknowledges the potential of our broad-spectrum antiviral approach,” said a company spokesperson. “This designation will help accelerate our development efforts and bring us closer to addressing a serious public health need.”
NV-387 has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events, and the company is now focused on advancing it into Phase II trials. The orphan drug status may streamline the clinical development process, as it often comes with additional regulatory support and reduced development costs.
For more details, the full press release is available at https://ibn.fm/uIWWv.
NanoViricides is a clinical-stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is a unique broad-spectrum antiviral. The company also has NV-HHV-1 in development for herpesvirus infections. More information about the company is available at https://www.nanoviricides.com.
The latest news and updates relating to NNVC can be found in the company’s newsroom at https://ibn.fm/NNVC.
