As measles cases climb across the United States and worldwide, 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 to evaluate NV-387 and intends to submit it for U.S. Food and Drug Administration (FDA) review through an Investigational New Drug (IND) process.
NV-387 has shown strong in vivo activity against lethal measles infection in a humanized animal model, according to the company. It has also received Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug Designation (RPDD) from the FDA for measles. The RPDD status could make NanoViricides eligible for a Priority Review Voucher upon approval of a qualifying marketing application, if all requirements are met.
“The continued rise in measles cases underscores the urgent need for effective treatments,” said a company spokesperson. “Our progress with NV-387 brings us closer to addressing this serious public health threat.”
Measles is a highly contagious viral disease that can lead to severe complications, especially in children. Despite the availability of a vaccine, outbreaks have been increasing in recent years due to factors such as vaccine hesitancy and international travel. The World Health Organization has reported a significant surge in cases, making the development of antiviral treatments a critical priority.
NanoViricides is a clinical-stage company focused on creating broad-spectrum antivirals using its host-mimetic nanomedicine technology. The company’s lead candidate, NV-387, is being developed to treat multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, and other respiratory viruses, as well as mpox/smallpox and measles.
In addition to its measles program, NanoViricides is advancing other drug candidates, including NV-HHV-1 for shingles and NV-CoV-2 for COVID-19. The company’s platform technology is based on intellectual property licensed from TheraCour Pharma, Inc., and it holds exclusive licenses for several viral disease targets.
The company emphasizes that drug development is a lengthy and capital-intensive process, and there is no guarantee that NV-387 or any other candidate will successfully complete clinical trials or gain regulatory approval. However, the FDA’s designations provide incentives to accelerate development, including potential priority review and market exclusivity.
“Receiving both Orphan Drug and Rare Pediatric Disease designations highlights the potential of NV-387 to address an unmet medical need,” the spokesperson added. “We are committed to advancing this program as quickly as possible.”
For more details on the company’s announcement, visit the full press release at https://ibn.fm/JFyfZ.
