NanoViricides, Inc. has signed a Master Services Agreement with regulatory consultant Only Orphans Cote to develop an orphan drug strategy for its lead antiviral candidate NV-387. The agreement, announced by the clinical-stage company, involves OOC preparing and prosecuting orphan drug designation applications at the US FDA Office of Orphan Products Development.
The company stated that NV-387 has demonstrated strong activity in lethal animal models of orthopoxvirus infections, supporting its potential for orphan designations targeting Smallpox, MPox, and Measles. Orphan drug status offers pharmaceutical companies several incentives including tax credits for clinical research, exemptions from certain FDA user fees, and up to seven years of market exclusivity upon approval.
NV-387 represents NanoViricides’ lead drug candidate, which the company plans to develop as a treatment for multiple viral infections including RSV, COVID, Long COVID, Influenza, and other respiratory viral diseases. The company’s technology platform is based on intellectual property licensed from TheraCour Pharma, Inc., with NanoViricides holding exclusive worldwide licenses for several viral disease applications.
The company maintains a comprehensive corporate website at https://www.nanoviricides.com where investors can find additional information about their programs. According to their business model, NanoViricides licenses technology from TheraCour Pharma for specific application verticals targeting particular viruses, as established when the company was founded in 2005.
Beyond NV-387, NanoViricides is developing other antiviral candidates including NV-HHV-1 for Shingles treatment and has research programs targeting numerous viral diseases such as oral and genital Herpes, viral eye diseases, various influenza strains, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. The company holds perpetual licenses for TheraCour’s nanomedicine technology for specific viral diseases including Human Immunodeficiency Virus, Hepatitis B and C viruses, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses.
The company noted that it intends to obtain additional licenses for RSV, Poxviruses, and/or Enteroviruses if initial research proves successful. NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials, though the company acknowledges the lengthy and capital-intensive nature of drug development and states it cannot project exact dates for filing Investigational New Drug applications due to dependence on external collaborators and consultants.
The regulatory partnership with Only Orphans Cote, founded by Dr. Timothy Cote, represents a strategic move to potentially accelerate and enhance the development pathway for NV-387 by pursuing orphan drug designations. This approach could provide financial and regulatory benefits that support the development of treatments for rare viral diseases that might otherwise receive limited pharmaceutical investment.
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