NanoViricides Advances Single Drug for Multiple Respiratory Virus Infections to Next Phase of Clinical Trials

NanoViricides, Inc. (NYSE American:NNVC), a leading clinical-stage company in antiviral nanomedicines, is advancing the development of NV-387, a promising drug showing effectiveness against a range of respiratory viral infections in animal models. The goal is to initiate human clinical trials for multiple indications.

Seasonal outbreaks of influenza, RSV, and COVID-19 have become common, and there is increasing concern over a potential severe pandemic caused by the Bird Flu virus, particularly H5Nx, which has recently led to the fifth human case in the USA. Despite the low current risk of human-to-human transmission, the virus has spread among wild birds and various mammals, including dairy cattle.

Additionally, MPox infections are becoming more frequent in the Western world, and the USA is experiencing a summer surge of COVID-19 cases due to new FLiRT variants. This highlights the inadequacy of the traditional approach of developing separate drugs for each virus, which is both costly and impractical given the numerous viruses affecting humans.

NV-387 offers a revolutionary approach by acting against multiple viruses, simplifying pandemic preparedness and reducing development costs. The drug has shown strong activity against RSV, Influenza, Coronaviruses, and orthoPoxviruses in animal models, surpassing approved drugs in effectiveness. Notably, it has completely cured RSV infections in animal studies and protected the lungs from damage, which is crucial for respiratory infections.

NV-387's unique mechanism of action, based on biomimicry, makes it difficult for viruses to develop resistance. It has successfully completed Phase I clinical trials with excellent safety results and no adverse events reported. The trial site is currently undergoing closure and audits to ensure regulatory compliance, with statistical data analysis to follow.

Plans for Phase II clinical studies of NV-387 as a treatment for RSV, Influenza, and COVID-19 are already in motion. NanoViricides aims to fast-track the regulatory approval process for NV-387 in various countries, including the USA.

NanoViricides, Inc. specializes in creating nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, targets respiratory viral infections like RSV, COVID-19, Long COVID, and Influenza. Another advanced candidate, NV-HHV-1, is aimed at treating Shingles. The company is advancing NV-387 into Phase I/II human clinical trials and has developed NV-CoV-2 for COVID-19, both with and without remdesivir encapsulation.

Besides these, NanoViricides is working on treatments for a range of viral diseases, such as oral and genital Herpes, eye infections, H1N1, H5N1 Bird Flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola. The company's platform technology is based on TheraCour® nanomedicine technology, licensed from AllExcel, and includes broad licenses for several viral diseases.

The company cautions that drug development is a lengthy and capital-intensive process, with no guarantees of success. Despite promising lab results, there is no certainty that these will translate into successful clinical trials or approved pharmaceutical products.