NanoViricides, Inc. (NYSE American:NNVC) is positioning its broad-spectrum antiviral drug candidate NV-387 as a potential weapon against a future H5N1 bird flu pandemic. The company asserts that the drug's unique mechanism of action, which mimics essential host-side features used by the virus, makes it unlikely for the virus to develop resistance, even with mutations.
Preclinical Efficacy
In preclinical animal studies involving lethal lung infection with Influenza A H3N2, NV-387 demonstrated an 88% increase in survival compared to existing treatments. Oseltamivir showed a 25% increase, while peramivir and baloxavir each showed a 38% increase in survival. These findings suggest a potentially superior efficacy of NV-387 in combating influenza infections.
Mechanism of Action
NV-387 is designed to target the poly-basic site on High-Path Avian Influenza A viruses, which binds to sulfated proteoglycans for cell entry. By mimicking this sulfated structure, NV-387 entraps the virus, potentially preventing infection. NanoViricides believes that the longer poly-basic site in H5N1 viruses may make them even more susceptible to NV-387 than seasonal influenza strains.
Clinical Development
NV-387 has successfully completed a Phase I human clinical trial, demonstrating excellent safety and tolerability with no reported adverse events or drop-outs. The company is now preparing for Phase II clinical trials to evaluate NV-387 for the treatment of MPox, which is currently an epidemic in Central Africa, and for respiratory virus infections, including influenza viruses, coronaviruses, and RSV.
Addressing Current Treatment Limitations
The World Health Organization (WHO) has noted that current H5N1 strains show reduced susceptibility to existing treatments like neuraminidase inhibitors (NAIs) and endonuclease inhibitors (PBIs). Anil R. Diwan, Ph.D., President and Executive Chairman of NanoViricides, stated that NV-387 puts the company in a strong position to combat a bird flu pandemic, should it occur, because the virus is unlikely to escape the drug's mechanism of action.
Implications for Pandemic Preparedness
Given the limitations of current H5N1 vaccines and the rapid mutation rate of influenza viruses, NanoViricides suggests that a drug the virus cannot escape is crucial for pandemic preparedness. The broad-spectrum antiviral activity of NV-387, encompassing viruses like COVID, RSV, influenza, and orthopoxviruses, supports its potential as a valuable tool in combating future viral outbreaks.
