NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, discusses its development program for NV-387, a single drug that has shown activity against many respiratory viral infections in animal models, enabling human clinical trials for a number of indications.
There are several viruses that continue to cause epidemics in humans; seasonal epidemics with Influenza, RSV, and SARS-CoV-2 (COVID) are occurring every year. The potential for severe Bird Flu pandemic, that may even be worse than the COVID-19 outbreak, is increasing every year as the virus spreads further into mammals and mutates more, according to experts.
Recently a fifth human case of H5Nx "Bird Flu" infection in the USA, acquired at work with infected dairy cattle, was found in Colorado (https://cdphe.colorado.gov/press-release/colorado-state-health-officials-identify-a-human-case-of-avian-flu). The person exhibited conjunctivitis symptoms, was given Tamiflu, and has recovered, according to the Colorado Department of Public Health and Environment (CDPHE). The risk to humans in general remains low, because this bird flu virus has not yet acquired the ability for human-to-human transmission, according to scientists. However, H5N1 bird flu is now widespread in wild birds, and has infected and spread in many mammals, including dairy cattle.
MPox infections are also becoming more common in the Western world over the last few years. MPox cases are rising in the USA again (https://www.nbcnewyork.com/news/national-international/mpox-cases-on-the-rise-in-connecticut-health-experts-say/5576427/).
A summer surge of COVID is occurring now with new FLiRT variants of the virus (https://www.forbes.com/sites/brucelee/2024/07/09/summer-2024-covid-19-surge-occurring-with-flirt-variants-taking-over/).
We are living in a world with many viruses that threaten our health. The current model of developing a drug against each virus separately is expensive and untenable with the myriad of viruses affecting humans that are gaining major foothold.
NV-387 turns this drug development model on its head, with a single drug that would be effective against many of these viruses. It simplifies preparedness for pandemics. It reduces cost of development to a single drug instance.
NV-387 is the only drug, to our knowledge, that has shown strong activity against all of the above viruses, namely, RSV, Influenza, Coronaviruses, and even orthoPoxviruses, in relevant animal models. In fact, in every case, the activity of NV-387 was superior to that of approved drugs as we have reported previously. NV-387 treatment also protected lungs from damage, which is very important for respiratory viral infections. Significantly, RSV infection in animals was completely cured by NV-387 treatment.
NV-387 is unlikely to be escaped by viruses, because of its biomimicry, presenting itself to the virus as a decoy of the host cell.
NV-387 has completed Phase I clinical trials with no reported adverse events, indicating excellent safety. Closing of the clinical trial site - hospital site itself - is in progress, with different audits taking place to ensure regulatory compliance. Statistical data analysis is expected to begin thereafter. We are eagerly awaiting further information and will provide updates as it becomes available.
We have started planning Phase II clinical studies of NV-387 as a treatment for RSV and other indications including Influenza and COVID, as the Phase I clinical trial comes to a close. We plan on taking the drug NV-387 forward on the fastest regulatory path feasible towards regulatory approvals in different countries and jurisdictions including the USA.
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