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, which the company believes will support regulatory advancement of NV-387. The broad-spectrum antiviral candidate has demonstrated in vivo activity against measles and is being developed to address rising global outbreaks, as noted in the press release. For more details, refer to the full press release at https://ibn.fm/uIWWv.
NV-387 is a unique broad-spectrum antiviral drug that NanoViricides plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections. It has also shown effectiveness in animal models for Monkeypox (MPox), Smallpox, and Measles. The company has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events and is currently focused on advancing NV-387 into Phase II human clinical trials. The Orphan Drug Designation underscores the potential of NV-387 to address unmet medical needs in measles treatment, especially given the resurgence of measles outbreaks globally.
NanoViricides is a clinical-stage company creating special purpose nanomaterials for antiviral therapy. Its other advanced drug candidate, NV-HHV-1, targets all Herpesvirus infections including HSV-1, HSV-2, VZV Shingles, and Chickenpox. The company cannot project an exact date for filing an IND for any of its drugs due to dependence on external collaborators and consultants. For the latest news and updates relating to NNVC, visit the company's newsroom at https://ibn.fm/NNVC.
The Orphan Drug Designation is a significant milestone for NanoViricides as it provides a pathway for expedited development and potential market exclusivity. Measles remains a highly contagious disease with serious complications, and despite the availability of vaccines, outbreaks continue to occur in various regions. The designation highlights the importance of developing effective antiviral treatments for measles, particularly for immunocompromised individuals or those who cannot be vaccinated. This recognition by the FDA may accelerate clinical trials and bring NV-387 closer to patients in need.
