As measles cases continue to rise in the United States and globally, NanoViricides, Inc. (NYSE American: NNVC) is advancing its experimental antiviral NV-387 toward clinical trials for the treatment of measles. The company announced that it is developing a Phase II clinical trial protocol and intends to submit it to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) process.
NV-387 has demonstrated strong in vivo activity 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 the treatment of measles. The RPDD designation could make NanoViricides eligible for a Priority Review Voucher upon approval of a qualifying marketing application, provided applicable requirements are met.
Measles is a highly contagious viral disease that can lead to severe complications, especially in children. The recent resurgence of measles cases in the U.S. and globally underscores the urgent need for effective treatments. Currently, there is no specific antiviral treatment for measles; care is supportive. If successful, NV-387 could fill a critical gap in the medical arsenal against this disease.
NanoViricides is a clinical-stage company focused on developing broad-spectrum antivirals based on host-mimetic nanomedicine technology. Its lead drug candidate, NV-387, is being developed as a treatment for multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, Long COVID, influenza, and other respiratory viral infections, as well as MPOX/smallpox and measles.
The company's platform technology is based on intellectual property licensed from TheraCour Pharma, Inc. NanoViricides holds exclusive, sub-licensable field licenses to drugs developed in several licensed fields. The company's business model involves licensing technology from TheraCour for specific application verticals of specific viruses, as established in 2005.
The announcement comes at a time when the global health community is grappling with declining vaccination rates and increased measles transmission. According to the World Health Organization, measles cases have surged by nearly 80% worldwide in 2023, highlighting the need for both preventive and therapeutic measures.
If NV-387 proves effective and safe in human trials, it could offer a treatment option for measles, potentially reducing the severity and duration of the illness and preventing complications. For the biotech industry, the advancement of this program represents progress in antiviral drug development beyond traditional targets, leveraging innovative nanomedicine approaches.
NanoViricides has a broad pipeline targeting various viral diseases, including herpes, hepatitis, influenza, and emerging viruses. The company is also developing NV-CoV-2 and NV-CoV-2-R for COVID-19, with the latter encapsulating remdesivir. The company believes that since remdesivir is already FDA-approved, NV-CoV-2-R could be an approvable drug if safety is comparable.
The path to drug approval is lengthy and requires substantial capital, and there is no assurance that NV-387 or any other candidate will demonstrate sufficient effectiveness and safety in human clinical trials. However, the FDA designations for measles indicate the potential value of this program and may provide incentives for development.
The company plans to focus on advancing NV-387 into Phase II human clinical trials. The specific timing for filing an IND depends on external collaborators and consultants, and the company cannot project an exact date at this time.
For more information about NanoViricides and its programs, visit the company's newsroom at https://ibn.fm/NNVC.
