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, which could accelerate the development and regulatory review of NV-387.
NV-387 is a broad-spectrum antiviral candidate that has demonstrated in vivo activity against measles and other viral infections. The company is developing NV-387 to address increasing global measles outbreaks, which have resurged due to declining vaccination rates in some regions. Measles remains a significant cause of morbidity and mortality worldwide, particularly in children under five years old.
The Orphan Drug Designation is a critical regulatory milestone that supports the advancement of NV-387 toward clinical trials. According to the company, NV-387 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 for respiratory viral infections, including RSV, COVID-19, Long COVID, and influenza, as well as for measles and other viral diseases.
“NV-387 is a unique broad-spectrum antiviral that is also effective in animal models for Monkeypox (MPox), Smallpox, as well as Measles,” the company stated in the press release. The drug’s broad-spectrum activity positions it as a potential therapeutic for multiple viral threats, which is particularly valuable in pandemic preparedness and outbreak response.
NanoViricides is a clinical-stage company specializing in creating special purpose nanomaterials for antiviral therapy. The company’s lead drug candidate, NV-387, is designed to mimic host cell receptors, thereby binding and neutralizing viruses before they can infect cells. This mechanism of action is distinct from traditional small-molecule antivirals and may offer advantages in terms of breadth of activity and resistance profile.
In addition to NV-387, NanoViricides is developing NV-HHV-1 for the treatment of all Herpesvirus infections, including HSV-1 (cold sores), HSV-2 (genital ulcers), VZV (shingles and chickenpox). The company has not yet projected an exact date for filing an Investigational New Drug (IND) application for any of its drugs, citing dependence on external collaborators and consultants.
For more information, visit the company’s newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/uIWWv.
