NanoViricides, Inc. (NYSE American: NNVC) announced that its clinical-stage antiviral drug NV-387 has been granted Orphan Drug Designation by the U.S. FDA for the treatment of measles. The designation provides potential incentives including tax credits, fee exemptions and market exclusivity, and supports the regulatory advancement of NV-387, a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles. The company is developing NV-387 to address rising global outbreaks, as measles cases have been increasing worldwide due to declining vaccination rates.
Orphan Drug Designation is granted by the FDA to drugs intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. However, measles is a highly contagious viral disease that can cause severe complications, especially in children. The designation underscores the urgent need for effective antiviral treatments, as current options are limited to supportive care and vaccination. NV-387 is a unique broad-spectrum antiviral that has shown efficacy in animal models for measles, as well as for monkeypox, smallpox, and other respiratory viral infections including RSV, COVID-19, and influenza.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate NV-387 has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events, and the company is currently focused on advancing NV-387 into Phase II human clinical trials. The Orphan Drug Designation may expedite the development process through additional FDA guidance and potential accelerated approval pathways.
The announcement comes at a time when global health authorities are warning about the resurgence of measles outbreaks. According to the World Health Organization, measles cases rose by 79% in 2022 compared to the previous year, driven by gaps in immunization coverage. The availability of an antiviral treatment could be crucial for managing cases in unvaccinated populations and for outbreak control. NV-387's broad-spectrum activity also positions it as a potential therapeutic for other viral threats, offering a versatile tool in the fight against emerging infectious diseases.
For more information, visit the company's newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/uIWWv.
