NanoViricides Provides Update on Antiviral Drug

NV-387, a new antiviral drug, is being hailed as a potential game-changer in the fight against viral infections, drawing comparisons to the historical impact of penicillin. Early non-clinical animal trials indicate that NV-387 outperforms or matches existing treatments against major respiratory viruses, including Influenza, COVID-19, and RSV, as well as orthopoxviruses like Smallpox and Mpox. The company is currently conducting a database audit of its Phase 1a/1b human clinical trials in India, while simultaneously preparing for a Phase II trial to assess the drug's effectiveness in humans. The unique broad-spectrum capabilities of NV-387 allow for the design of an innovative adaptive clinical trial, which could evaluate its efficacy against multiple respiratory viruses within a single study. The company plans to submit a Pre-IND application to the US FDA, as well as seek guidance from regulatory bodies in other regions, to further advance the clinical program for NV-387. This drug candidate is particularly focused on treating RSV, COVID-19, Long COVID, and Influenza. Additionally, NV-CoV-2, a nanoviricide drug candidate for COVID-19, is being developed without encapsulating remdesivir, which is already FDA-approved. The company believes that encapsulating remdesivir in their drug candidate could lead to a favorable approval process, provided safety standards are met. However, the company acknowledges the inherent uncertainties in drug development, emphasizing that there is no guarantee of success in demonstrating safety and effectiveness in clinical trials or obtaining necessary regulatory approvals.