NanoViricides, Inc. (NYSE American: NNVC) announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its clinical-stage antiviral drug NV-387 for the treatment of measles. The designation, which provides potential incentives including tax credits, fee exemptions and market exclusivity, supports the regulatory advancement of NV-387 as the company works to address rising global outbreaks of the highly contagious disease.
NV-387 is a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles, according to the company. The drug candidate has already successfully completed a Phase I human clinical trial 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 a significant milestone for the company, as it may accelerate the development and review process for NV-387. Under the Orphan Drug Act, the FDA grants such designation to drugs intended to treat rare diseases affecting fewer than 200,000 people in the United States. However, measles cases have been on the rise globally, with outbreaks reported in multiple countries due to declining vaccination rates.
NanoViricides is a clinical stage company specializing in creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is a broad-spectrum antiviral that the company plans to develop as a treatment for RSV, COVID-19, Long COVID, influenza and other respiratory viral infections. In addition to measles, NV-387 has shown effectiveness in animal models for monkeypox (MPox) and smallpox.
The company also has another advanced drug candidate, 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 application for any of its drugs due to dependence on external collaborators and consultants.
Investors and industry observers are closely watching NanoViricides' progress, as the company's broad-spectrum antiviral platform could address multiple viral threats. The full press release detailing the Orphan Drug Designation is available at https://ibn.fm/uIWWv.
For more information about NanoViricides, visit the company's website at www.nanoviricides.com. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.
