NanoViricides’ NV-387 Receives FDA Orphan Drug Designation for Measles Treatment

NanoViricides, Inc. (NYSE American: NNVC) has announced that its clinical-stage antiviral drug NV-387 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration 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.

The company noted that NV-387 has demonstrated in vivo activity against measles and is being developed to address rising global outbreaks. Measles remains a significant public health concern, with outbreaks occurring in various regions due to gaps in vaccination coverage. The Orphan Drug Designation is a key milestone that could accelerate the development and review process for NV-387.

According to the press release, NV-387 is a unique broad-spectrum antiviral that has shown effectiveness in animal models against not only measles but also monkeypox (MPox), smallpox, and other respiratory viral infections. The drug has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events, and NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials.

NanoViricides is a clinical-stage company specializing in creating special purpose nanomaterials for antiviral therapy. The company’s lead drug candidate, NV-387, is intended for the treatment of RSV, COVID-19, Long COVID, influenza, and other respiratory viral infections. Additionally, the company is developing NV-HHV-1 for herpesvirus infections including HSV-1, HSV-2, VZV shingles, and chickenpox.

The Orphan Drug Designation is expected to provide NanoViricides with several benefits, including a potential seven-year market exclusivity upon FDA approval, tax credits for clinical trial costs, and waived user fees. This designation is particularly important for diseases like measles, which, despite being vaccine-preventable, continues to cause outbreaks worldwide. The World Health Organization has reported increasing measles cases in many countries, highlighting the need for effective treatments.

NanoViricides’ CEO, Dr. Anil R. Diwan, stated in the release, ‘We are very pleased to receive Orphan Drug Designation for NV-387 for the treatment of measles. This designation underscores the potential of NV-387 to address a serious and life-threatening disease with high unmet medical need.’ The company is committed to advancing NV-387 through clinical development to bring a much-needed antiviral option to patients.

For more information about NanoViricides, visit the company’s website at https://www.nanoviricides.com. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.

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