NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage developer of broad-spectrum antivirals, has announced progress in its NV-387 measles treatment program as measles cases continue to rise both in the United States and globally. The company is preparing a Phase II clinical trial protocol to evaluate NV-387 as a therapeutic for measles, with plans to submit it to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. This development is significant given the recent resurgence of measles, a highly contagious viral disease that can lead to severe complications, especially in children.
NV-387 has already demonstrated strong in vivo efficacy against lethal measles infection in a humanized animal model. Importantly, the FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) Designation for the treatment of measles. The RPDD status is particularly valuable because it makes NanoViricides eligible for a Priority Review Voucher (PRV) upon approval of a qualifying marketing application, provided all applicable requirements are met. PRVs can be sold or transferred, potentially providing substantial financial benefits to the company.
The advancement of NV-387 comes at a critical time. Measles, which was declared eliminated in the U.S. in 2000, has seen a resurgence in recent years due to declining vaccination rates. According to the Centers for Disease Control and Prevention (CDC), measles cases in the U.S. have been on the rise in 2025, with outbreaks reported in multiple states. Globally, the World Health Organization has warned of an increased risk of measles outbreaks due to gaps in immunization coverage. If left untreated, measles can lead to pneumonia, encephalitis, and other serious complications, particularly in young children and immunocompromised individuals.
There is currently no specific antiviral treatment for measles; management typically involves supportive care, vitamin A supplementation, and treatment of complications. The development of an effective antiviral could fill an unmet medical need, offering a therapeutic option for infected individuals and potentially reducing the severity and duration of the illness.
NanoViricides' platform technology is based on host-mimetic nanomedicine, which uses specially designed nanomaterials that mimic host cell receptors to attract and neutralize viruses. This approach is broad-spectrum, meaning it can potentially target multiple viruses. NV-387 is the company's lead drug candidate and is also being developed for other respiratory viral infections, including RSV, COVID-19, and influenza. The company has obtained broad, exclusive, sub-licensable field licenses from TheraCour Pharma for specific applications, and its business model relies on licensing this technology for various viral targets.
The path to drug development is long and capital-intensive, and NanoViricides acknowledges the inherent risks. There is no assurance that NV-387 will demonstrate sufficient safety and efficacy in clinical trials to gain regulatory approval. However, the FDA designations and the pressing public health need highlight the importance of this program. The company's focus on advancing NV-387 into Phase II trials underscores its commitment to addressing viral threats beyond the well-known COVID-19, potentially providing new tools to combat future outbreaks.
For more information on NanoViricides and its programs, visit NanoViricides' website. The full press release is available at this link.
