NanoViricides, Inc. is making strides with its antiviral drug candidate, NV-387, a broad-spectrum antiviral nanomedicine. NV-387 is designed to mimic the ubiquitous sulfated-proteoglycan (S-PG) features that over 90% of pathogenic human viruses utilize to infect human cells, potentially disabling virus particles from infecting cells. This approach could revolutionize antiviral therapeutics, similar to the impact of penicillin on bacterial infections.
Preclinical Efficacy Against Key Respiratory Viruses
Non-clinical animal trials have demonstrated NV-387's effectiveness against major viral classes, including Influenza, COVID-19, and RSV. Notably, in an RSV efficacy study, NV-387 led to complete survival of lethally lung-infected mice, with full protection of the lungs, suggesting a potential cure. The company emphasizes that current treatments for RSV, like Ribavirin, have limitations and toxicity.
Addressing Viral Resistance
NanoViricides believes the broad-spectrum nature of NV-387 makes it unlikely for viruses to develop substantial resistance, a common issue with conventional medical countermeasures (MCMs) like vaccines and small molecule antivirals. The company aims to investigate NV-387's effectiveness against a wide array of S-PG-using viruses, including Dengue, Zika, Ebola, and others.
Clinical Trial Progress and Strategy
NanoViricides is currently auditing the database from its Phase 1a/1b clinical trial of NV-387 in healthy subjects in India. Following data lock and statistical analysis, a final Phase I clinical trial report will be prepared. Simultaneously, the company is advancing preparations for a Phase 2 clinical trial to evaluate NV-387's antiviral effectiveness in humans, including initiating non-clinical GLP animal studies with reports expected by the end of CY 2025.
Adaptive Clinical Trial Design
NanoViricides is exploring a novel, adaptive clinical trial design for Phase 2, which could evaluate NV-387's effectiveness against multiple respiratory viruses in a single trial. This approach could accelerate the identification of viruses against which NV-387 is most effective, guiding further regulatory clinical development.
Targeting Pediatric RSV
The company is also designing a traditional Phase 2 human clinical trial with the goal of regulatory approval of NV-387 for treating pediatric RSV disease. A Pre-IND application with the US FDA or equivalent applications in other regulatory regions is planned to guide the clinical program.
Market Opportunity
The combined market for Influenza, RSV, and COVID-19 is estimated to be over $8 billion in 2024, projected to grow to $12 billion in three years. NanoViricides aims to expand the applicability of NV-387 to other viral infections, mirroring the broad use of antibiotics for bacterial infections.
Collaborations and Future Development
NanoViricides has initiated outreach to secure collaborations with larger pharmaceutical companies to expedite its programs and secure financing, building on progress made in FY 2024.
