NanoViricides Partners with Regulatory Consultant to Pursue Orphan Drug Status for Broad-Spectrum Antiviral NV-387

NanoViricides, Inc., a clinical stage company developing broad-spectrum antivirals based on host-mimetic nanomedicine, has signed a Master Services Agreement with regulatory consultant Only Orphans Cote to develop an orphan drug strategy for its lead candidate NV-387. The agreement, announced through a press release available at https://ibn.fm/2NRpu, involves OOC preparing and prosecuting orphan drug designation applications at the US FDA Office of Orphan Products Development. This strategic move could provide significant advantages for the company's development pathway for NV-387, which has shown strong activity in lethal animal models of orthopoxvirus infections.

The orphan drug designation process is crucial for pharmaceutical companies developing treatments for rare diseases, as it offers several important incentives. According to the announcement, orphan drug status may provide tax credits, user-fee exemptions, and up to seven years of market exclusivity upon approval. For NanoViricides, this strategy supports potential orphan designations for Smallpox, MPox, and Measles treatments using NV-387. The company's website at https://www.nanoviricides.com provides additional information about their platform technology and development programs.

NV-387 represents NanoViricides' lead drug candidate, which the company plans to develop as a treatment for multiple respiratory viral infections including RSV, COVID, Long COVID, and Influenza, in addition to MPOX/Smallpox infections. The company's technology is based on intellectual property licensed from TheraCour Pharma, Inc., with broad, exclusive, sub-licensable field licenses for drugs developed in several licensed fields. NanoViricides' business model, established at its foundation in 2005, centers on licensing technology from TheraCour for specific application verticals of specific viruses.

The company is currently focused on advancing NV-387 into Phase II human clinical trials, though it cannot project an exact date for filing an Investigational New Drug application due to dependence on external collaborators and consultants. Beyond NV-387, NanoViricides is developing other antiviral candidates including NV-HHV-1 for Shingles treatment and drugs against numerous other viral diseases such as oral and genital Herpes, viral eye diseases, various influenza strains, HIV, Hepatitis C, and Ebola virus. The company holds worldwide exclusive perpetual licenses for TheraCour's nanomedicine technology for treating specific human viral diseases.

This regulatory partnership comes at a critical time for antiviral development, as the COVID-19 pandemic has highlighted the need for effective broad-spectrum antiviral treatments. The orphan drug strategy for NV-387 could accelerate development pathways for treatments targeting rare viral diseases while providing financial incentives that support the substantial capital requirements of drug development. As with all pharmaceutical development, the company notes there can be no assurance that its candidates will show sufficient effectiveness and safety for human clinical development or that successful laboratory results will lead to successful clinical trials or products.