NV-387 Orally Cures Lethal RSV in Animals

NanoViricides, Inc., a recognized leader in the field of broad-spectrum antiviral nanomedicines, has announced promising results for its antiviral drug candidate NV-387. In the recently conducted study, NV-387 demonstrated strong efficacy against Respiratory Syncytial Virus (RSV) infection in an animal model. The study showed that animals treated with NV-387 displayed no infection-related lung damage and had normal lung conditions after being administered the drug orally. This finding indicates that NV-387 could potentially serve as a cure for RSV infection.

The study compared the effects of oral NV-387 with a high dose of ribavirin, another antiviral medication. Animals received two doses of NV-387 on the first day, followed by a single daily dose for the next nine days, totaling 11 doses. Throughout the study, the NV-387 treated group exhibited no lung damage at any time points evaluated. This comprehensive protection resulted in the complete survival of all animals in the treated group beyond the 21-day study period.

Conversely, the group treated with ribavirin exhibited progressive lung pathology. By the 10th day, animals showed moderate inflammation and infected cells in the lung tissue, which worsened by the 13th day, leading to severe pneumonia and alveolitis. All animals in the ribavirin-treated group died by the 14th day of the study.

These significant findings underscore the therapeutic potential of NV-387 in treating RSV infections. Currently, there are no approved treatments for RSV other than ribavirin, which is known for its toxicity and is considered a last-resort medication. The development of a safe and effective treatment for RSV remains an unmet medical need.

Dr. Anil R. Diwan, the President of NanoViricides, Inc., expressed optimism regarding the results. He highlighted the potential clinical value of NV-387 for protecting vulnerable populations such as infants and children from RSV. The company plans to advance NV-387 into clinical trials for RSV treatment as soon as possible.

RSV is a significant health concern, especially for infants, children under five, and older adults over 65. According to the Centers for Disease Control and Prevention (CDC), RSV annually results in approximately 58,000 to 80,000 hospitalizations among children younger than five years old and 60,000 to 160,000 hospitalizations among adults 65 years and older in the United States. Additionally, RSV is responsible for 6,000 to 10,000 deaths among older adults and 100 to 300 deaths in young children each year.

While two vaccines have recently been approved for individuals over 60 years old, there is still a pressing need for effective treatments. The vaccines, Arexvy by GSK and Abrysvo by Pfizer, offer protection but do not address treatment needs. Additionally, antibodies such as palivizumab (Synagis) and nirsevimab (Beyfortus) have been approved for preventing RSV in newborns at risk but are not treatments for active infections.

NanoViricides, Inc. is focused on developing novel antiviral therapies using nanomaterials designed to specifically target and dismantle virus particles. Their lead drug candidate, NV-387, has successfully undergone Phase 1a/1b human clinical trials with no reported adverse effects even at high doses. The company is now gearing up to move NV-387 into Phase II clinical trials for RSV treatment.

Additionally, NanoViricides is working on other advanced drug candidates, including NV-HHV-1 for herpes-related infections. The company's broad pipeline includes treatments for a variety of viral diseases such as shingles, influenza, HIV, hepatitis, and Ebola, among others. The platform technology used by NanoViricides is licensed from TheraCour Pharma, Inc., and focuses on creating drugs that target specific viral mechanisms to prevent the viruses from escaping treatment even as they mutate.

While the path to drug development is lengthy and requires substantial investment, the promising results for NV-387 bring hope for effective RSV treatments and potentially other viral infections in the future.