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. This designation provides potential incentives including tax credits, fee exemptions, and market exclusivity, supporting the regulatory advancement of NV-387 as a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles. The company is developing NV-387 to address the increasing global outbreaks of measles, a highly contagious viral disease.
NV-387 is a unique broad-spectrum antiviral drug that NanoViricides plans to develop for the treatment of respiratory syncytial virus (RSV), COVID-19, Long COVID, influenza, and other respiratory viral infections. The drug has also shown effectiveness in animal models for monkeypox (MPox), smallpox, and measles. With the Orphan Drug Designation, NanoViricides gains access to various development incentives, including tax credits for clinical trial costs, waiver of FDA application fees, and seven years of market exclusivity upon approval.
The company previously completed a Phase I human clinical trial of NV-387 in healthy volunteers with no reported adverse events. NanoViricides is now focused on advancing NV-387 into Phase II human clinical trials. The Orphan Drug Designation is expected to facilitate the regulatory process and potentially accelerate the development timeline for the drug. According to the company, this designation underscores the unmet medical need for effective measles treatments, especially in light of rising global outbreaks.
Measles remains a significant public health concern despite the availability of vaccines. The World Health Organization has reported increasing cases in recent years, highlighting the need for antiviral therapies. NanoViricides' NV-387 could provide a treatment option for infected individuals, particularly in outbreak settings.
For more information, see the full press release at https://ibn.fm/uIWWv. Updates on NanoViricides are available in the company's newsroom at https://ibn.fm/NNVC.
