As measles cases surge across the United States and globally, NanoViricides, Inc. (NYSE American: NNVC) is pushing forward with its NV-387 measles treatment program. The clinical-stage company announced it is developing a Phase II clinical trial protocol to evaluate NV-387 as a therapeutic for measles and plans to submit the protocol to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) process.
NV-387 has demonstrated robust in vivo efficacy against lethal measles infection in a humanized animal model, according to the company. It has also received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) Designation from the FDA for measles treatment. The RPDD status could make NanoViricides eligible for a Priority Review Voucher upon approval of a qualifying marketing application, provided all requirements are met.
The announcement comes at a critical time. Measles, a highly contagious viral disease, has seen a resurgence in recent years due to gaps in vaccination coverage. The World Health Organization reported a 20-fold increase in measles cases in Europe in 2023, and the U.S. has experienced multiple outbreaks. Current treatment options are limited to supportive care, making the development of an effective antiviral a significant unmet medical need.
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 is designed to be broad-spectrum, meaning NV-387 could potentially target multiple viruses. Indeed, NanoViricides plans to develop NV-387 for respiratory syncytial virus (RSV), COVID-19, long COVID, influenza, and other respiratory infections, as well as mpox/smallpox and measles.
The company’s lead drug candidate, NV-387, is the active pharmaceutical ingredient in its COVID-19 candidates NV-CoV-2 and NV-CoV-2-R. While NV-CoV-2 is a standalone nanoviricide, NV-CoV-2-R encapsulates remdesivir, an FDA-approved antiviral. NanoViricides believes that NV-CoV-2-R, if it demonstrates comparable safety, could be an approvable drug given remdesivir’s existing approval.
Beyond measles and COVID-19, NanoViricides is developing treatments for a range of viral diseases, including herpes simplex, viral eye infections, influenza, HIV, hepatitis C, rabies, dengue, and Ebola. The company holds exclusive, sub-licensable licenses from TheraCour Pharma for several antiviral applications, and its technology is based on TheraCour’s nanomedicine platform.
The path to approval for NV-387 as a measles treatment is still lengthy and capital-intensive. NanoViricides acknowledges that there is no assurance that its drug candidates will demonstrate sufficient efficacy and safety in human trials. However, the FDA designations provide incentives and expedited review pathways that could accelerate development.
The company’s focus on advancing NV-387 into Phase II trials signals a strategic priority to address urgent public health threats. With measles cases rising, an effective antiviral could be a crucial tool in managing outbreaks, especially in unvaccinated or immunocompromised populations.
For more information on NanoViricides and its programs, visit the company’s newsroom at https://ibn.fm/NNVC.
