As measles cases continue to climb in the United States and around the world, NanoViricides, Inc. (NYSE American: NNVC) is advancing its experimental treatment, NV-387, toward a Phase II clinical trial. The company, a clinical-stage developer of broad-spectrum antivirals based on host-mimetic nanomedicine technology, announced it is developing a protocol to evaluate NV-387 as a therapeutic for measles. NanoViricides intends to submit the protocol to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) process, a critical step toward human testing.
NV-387 has already demonstrated strong in vivo activity against lethal measles infection in a humanized animal model, according to the company. Additionally, the FDA has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) Designation for NV-387 in the treatment of measles. The RPDD designation is particularly significant because it makes NanoViricides eligible to receive a Priority Review Voucher (PRV) upon approval of a qualifying marketing application, provided all requirements are met. PRVs can be sold or transferred and have historically fetched hundreds of millions of dollars, providing a potential financial incentive beyond the drug's therapeutic value.
The urgency of developing effective measles treatments is underscored by recent epidemiological data. According to the U.S. Centers for Disease Control and Prevention, measles cases in the U.S. have surged in recent months, with outbreaks in multiple states, including Texas and New Mexico. Globally, the World Health Organization has reported a rise in measles cases, with many countries experiencing disruptions in routine vaccination coverage. Measles is highly contagious and can lead to severe complications, particularly in young children, including pneumonia, encephalitis, and death.
NanoViricides' platform technology is based on the nanoviricide(TM) approach, which uses specially designed nanomaterials that mimic host cell receptors to attract and neutralize viruses. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, and other respiratory viruses, as well as MPOX/smallpox and measles. The company is also developing NV-HHV-1 for shingles.
The company's business model involves licensing technology from TheraCour Pharma, Inc., with which it has a memorandum of understanding for developing drugs based on these technologies for all antiviral infections. NanoViricides holds exclusive, sub-licensable field licenses for several viral indications, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, and certain Coronaviruses.
Moving NV-387 into Phase II trials for measles would mark a significant milestone for the company, which has yet to bring any drug to market. The company acknowledges the lengthy and capital-intensive nature of drug development and notes that there is no guarantee that any of its candidates will prove safe and effective in humans. However, the progress of NV-387, combined with the FDA's designations and the pressing public health need, underscores the potential importance of this program.
The full press release is available at https://ibn.fm/JFyfZ. For more information about NanoViricides, visit the company's website at www.nanoviricides.com.
