NanoViricides, Inc. (NYSE American: NNVC) announced that its clinical-stage antiviral drug 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 upon approval. The company stated that the designation supports the regulatory advancement of NV-387, a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles and is being developed to address rising global outbreaks.
NV-387 is a unique broad-spectrum antiviral drug that the company plans to develop for treating respiratory viral infections such as RSV, COVID-19, Long COVID, and influenza. It has also shown effectiveness in animal models for Monkeypox (MPox), Smallpox, and Measles. The drug successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events, and the company is now focused on advancing NV-387 into Phase II human clinical trials.
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. Measles, while highly contagious, has seen a decline in cases due to vaccination, but recent global outbreaks have highlighted the need for effective treatments. The designation provides NanoViricides with several benefits, including tax credits for clinical trial costs, waiver of FDA user fees, and seven years of market exclusivity upon approval, which can significantly reduce development costs and provide a competitive advantage.
This announcement comes as the World Health Organization reports a resurgence of measles cases worldwide, driven by gaps in vaccination coverage. An effective antiviral treatment like NV-387 could play a critical role in managing outbreaks and protecting vulnerable populations. The company's progress with NV-387 underscores its commitment to addressing unmet medical needs in infectious diseases.
For more information, visit the company's newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/uIWWv.
