As measles cases continue to surge across the United States and globally, NanoViricides, Inc. (NYSE American: NNVC) is advancing its lead antiviral candidate, NV-387, toward a Phase II clinical trial for the treatment of measles. The company announced that it is developing a clinical trial protocol and plans to submit it to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. This move comes at a critical time when public health officials are grappling with outbreaks fueled by declining vaccination rates.
NV-387 has already demonstrated potent in vivo activity against lethal measles infection in a humanized animal model, according to the company. Importantly, the FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug Designation (RPDD) for NV-387 in the treatment of measles. The RPDD is particularly significant because it makes NanoViricides eligible to receive a Priority Review Voucher upon approval of a qualifying marketing application, provided all requirements are met. Such vouchers can be sold or transferred, offering a potential financial windfall and expedited review for another product.
The push toward clinical development aligns with the urgent need for antiviral treatments for measles. Current medical care is largely supportive, as there is no specific antiviral therapy approved for measles. The disease can lead to severe complications, including pneumonia, encephalitis, and death, especially in young children and immunocompromised individuals. With measles cases rising in pockets of the U.S. and many other countries, an effective treatment would fill a critical gap in pandemic preparedness and public health response.
NanoViricides’ platform technology is based on host-mimetic nanomedicine, which uses specially engineered nanomaterials that mimic host cell receptors to attract and neutralize viruses. This approach offers a broad-spectrum mechanism that could be effective against multiple viral infections. NV-387 is the company’s lead drug candidate and is also being developed for respiratory syncytial virus (RSV), COVID-19, influenza, and other respiratory infections, as well as poxviruses and measles. The company’s pipeline includes NV-CoV-2, a COVID-19 candidate, and NV-CoV-2-R, which encapsulates remdesivir, an FDA-approved antiviral.
The company’s strategic focus on measles is noteworthy given the recent outbreaks. According to the Centers for Disease Control and Prevention (CDC), measles cases in the U.S. have increased in recent years, with many cases linked to international travel and unvaccinated communities. The World Health Organization has also reported a global rise in measles cases, with over 9 million cases and 128,000 deaths in 2021 alone. The availability of a treatment could help reduce the severity of outbreaks and save lives, particularly in settings where vaccination is not universally accepted or accessible.
The RPDD and ODD designations provide incentives for the development of therapies for rare pediatric diseases and conditions affecting small populations. Measles is not typically considered a rare disease in developing countries, but in the U.S., the incidence is low enough to qualify for these designations. The Priority Review Voucher, if granted, could be a significant asset for NanoViricides, which is still in the clinical stage and has yet to generate revenue from product sales.
NanoViricides is also focused on advancing its broader pipeline, including treatments for shingles (NV-HHV-1) and other viral infections. The company holds extensive intellectual property and licenses from TheraCour Pharma, Inc., covering a wide range of viral targets. However, the development path for any pharmaceutical is lengthy and capital-intensive, and there is no guarantee that NV-387 will ultimately receive regulatory approval.
For more information on NanoViricides and its programs, visit www.nanoviricides.com. The full press release is available at https://ibn.fm/JFyfZ.
