As measles cases continue to climb in the United States and around the world, NanoViricides, Inc. (NYSE American: NNVC) is advancing its antiviral candidate NV-387 toward a Phase II clinical trial for the treatment of measles. The company announced it is developing a trial protocol and intends to submit it to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) process.
The urgency of the program is underscored by recent measles outbreaks that have prompted public health warnings. In this context, NanoViricides reports that NV-387 has demonstrated strong in vivo activity against lethal measles infection in a humanized animal model. The candidate has already received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) Designation from the FDA for measles. The RPDD is particularly significant because it could make the company eligible for a Priority Review Voucher upon approval of a qualifying marketing application, a valuable incentive that can be sold or transferred.
“The rise in measles cases highlights the need for effective antiviral treatments,” said a company spokesperson. “We are encouraged by the preclinical data and are moving expeditiously to bring NV-387 into human trials.”
NV-387 is the company’s lead drug candidate, a broad-spectrum antiviral designed to mimic host cells to attract and neutralize viruses. It is being developed for multiple indications, including respiratory syncytial virus (RSV), COVID-19, influenza, and other respiratory infections, as well as poxviruses and measles. The company’s nanoviricide technology, based on TheraCour Pharma’s platform, involves polymeric micelles that can be tailored to target specific viruses.
The move to Phase II comes as the company also advances NV-387 for other indications. Earlier, NanoViricides reported positive results for NV-387 against COVID-19 and RSV in preclinical studies. The measles program, however, has gained particular traction due to the FDA designations and the current epidemiological context.
According to the World Health Organization, measles cases increased by 79% globally in 2023 compared to 2022, and outbreaks have been reported in multiple U.S. states in 2024. The disease can lead to severe complications, especially in children, including pneumonia and encephalitis. While vaccination is highly effective, coverage has declined in some areas, leading to renewed vulnerability.
NanoViricides’ development of NV-387 for measles is part of a broader strategy to address unmet medical needs in antiviral therapy. The company is also working on candidates for herpes, HIV, hepatitis, and other viral diseases. However, the measles program is among the most advanced, with the company targeting an IND submission in the near future.
The FDA’s Orphan Drug Designation provides incentives such as tax credits for clinical testing and seven years of market exclusivity upon approval. The Rare Pediatric Disease Designation, which applies to serious or life-threatening diseases affecting fewer than 200,000 people in the U.S. and primarily children, offers the potential for a Priority Review Voucher. This voucher can be used to expedite review of a future drug application or sold to another company, representing a significant financial asset.
“Receiving both designations underscores the potential of NV-387 to address a serious unmet need in measles treatment,” the spokesperson added. “We look forward to working with the FDA to advance this program.”
The company’s progress is being closely watched by investors and public health officials alike. With measles resurgent, an effective antiviral could provide a critical tool for treating infected individuals, especially those who are unvaccinated or immunocompromised.
NanoViricides plans to provide further updates as it finalizes the Phase II trial protocol and engages with the FDA. The company emphasizes that the path to drug approval is lengthy and capital-intensive, and there is no guarantee of success. Nevertheless, the advancement of NV-387 into later-stage trials represents a meaningful step toward a potential new therapy for a disease that remains a global health threat.
For more information about NanoViricides and its programs, visit the company’s website at NanoViricides.com. The full press release is available at https://ibn.fm/JFyfZ.
