NanoViricides, Inc. (NYSE American: NNVC) has announced promising data regarding its investigational therapeutic, NV-387, showcasing broad-spectrum antiviral activity and safety in preclinical studies. The data indicates NV-387's potential efficacy against a range of viruses, including those responsible for the "tripledemic" – coronaviruses, respiratory syncytial virus (RSV), and influenza A viruses, including the highly pathogenic avian influenza H5N1 virus.
Superior Antiviral Effects Against Influenza
In a lethal animal model of lung infection induced by the influenza A/H3N2 virus, NV-387 exhibited substantially superior antiviral effects compared to three approved anti-influenza drugs: Oseltamivir, Peramivir, and Baloxivir. This suggests NV-387 could offer a more effective treatment option for influenza infections.
Efficacy Against Orthopoxviruses
NV-387 has also demonstrated effectiveness against the orthopoxvirus family, which includes Smallpox and Mpox, in both inhalation and skin abrasion modes of transmission. In a lethal animal model of lung infection by the Ectromelia virus, a surrogate model for Smallpox and Mpox infection in humans, NV-387 treatment led to a significant increase in the lifespan of the mice, comparable to that achieved with oral administration of tecovirimat, an approved Smallpox drug. Notably, when NV-387 was given in combination with tecovirimat, an improved effect was observed, potentially due to their different mechanisms of action.
Host-Mimetic Technology
NV-387 utilizes a host-mimetic technology, leveraging unchanging host-side landing sites to act as decoys, making it effective against viruses even as they evolve. Most human pathogenic viruses use common landing sites known as Sulfated Proteoglycans (SPG). NV-387, which mimics SPG, potentially targets a vast array of viruses by acting as a cell-mimicking decoy.
Clinical Development and Safety Profile
According to NanoViricides, NV-387's formulation has demonstrated a high safety profile in preclinical studies, with no observed adverse events (NOAEL: 1,200mg/Kg; MTD: 1,500mg/Kg). It is non-mutagenic, non-genotoxic, and non-immunogenic. Phase I clinical trials of NV-387, administered as an oral syrup and gummies, reported no adverse events, even at high doses. The company is now preparing for Phase II trials to evaluate its efficacy against RSV infections.
Future Prospects
NanoViricides CEO Dr. Anil Diwan highlighted the potential impact of NV-387, stating its possible significance in antiviral treatments could be compared to penicillin’s role in antibacterial therapy. The company aims to secure regulatory approvals globally for NV-387 and is ready to advance the drug into clinical trials pending regulatory timelines.
