NV-387: New Broad-Spectrum Antiviral for Bird Flu H5N1, Says NanoViricides

NanoViricides, Inc., a clinical-stage company specializing in antiviral nanomedicines, has announced promising results for its ultra-broad-spectrum antiviral drug candidate NV-387 in combating bird flu H5N1 viruses. The company, listed on NYSE American under the ticker NNVC, revealed that NV-387 outperformed three currently approved influenza drugs—Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®, Biocryst), and Baloxavir (Xofluza®, Shionogi, Roche)—in an animal model study of Influenza A/H3N2. This study showed that NV-387 not only reduced viral damage but also protected the lungs from immune system damage, indicating a potent antiviral effect.

The timing of these findings is critical as the threat of bird flu H5N1 has risen significantly. The virus has spread to several mammal species, with fatal brain infections noted in farm cats, and mild infections observed in dairy cattle. Currently, there have been four human cases, with one fatality in Mexico and three recoveries in the USA.

NV-387 stands out as a promising drug due to its effectiveness against the HPAI H5N1 virus, even when mutations occur. This is attributed to the presence of the Multi-Basic Site (MBS) in the hemagglutinin (H5) protein of HPAI H5N1, which interacts strongly with sulfated proteoglycans (S-PG). NV-387 is designed to mimic these S-PG, enhancing its efficacy against viruses that use this attachment site, such as HPAI H5N1.

Additionally, NV-387's broad-spectrum activity extends to various viruses, including Influenza A, RSV, COVID-19, seasonal coronaviruses, and even poxviruses. This wide-ranging effectiveness is possible due to NV-387's ability to mimic the invariant attachment site common to these viruses. The drug's potential to remain effective despite viral mutations contrasts sharply with existing drugs, where single-point mutations can lead to resistance.

The risk of a pandemic due to HPAI H5N1 is significant, as only a few mutations in the hemagglutinin protein could enable the virus to efficiently infect humans, with potentially higher fatality rates than COVID-19. Influenza viruses, known for their high mutation rates and ability to reassort genetic segments, pose a daunting challenge to antiviral drug development.

NanoViricides aims to address this challenge with its platform technology. The company is developing nanomaterials specifically designed to attack and dismantle enveloped virus particles. Their lead candidate, NV-CoV-2, targets COVID-19 and other respiratory infections, while another candidate, NV-HHV-1, is intended for treating shingles.

The development of NV-CoV-2 includes two versions: one as a stand-alone drug and the other encapsulating remdesivir, an already FDA-approved antiviral. This dual approach aims to enhance the drug's approval likelihood based on safety comparability with remdesivir.

NanoViricides is also exploring treatments for a wide array of viral diseases, such as herpes, eye infections, various influenza strains, HIV, hepatitis, rabies, dengue fever, and Ebola. Their technology, based on TheraCour® nanomedicine, involves exclusive, perpetual licenses for developing drugs targeting specific viral mechanisms.

The company's business model relies on licensing technology from TheraCour Pharma Inc., focusing on specific viruses as defined during its establishment in 2005. Despite the lengthy and capital-intensive process of drug development, NanoViricides remains committed to advancing its antiviral candidates through rigorous research and trials.

While promising, the effectiveness and safety of these candidates still need validation through clinical trials. The company stresses that successful laboratory results do not necessarily guarantee success in human trials, underscoring the inherent uncertainties in pharmaceutical development.