NanoViricides, Inc. reported that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully. Recruitment for the Multiple-Ascending Dose parts was also completed. The drug NV-CoV-2 contains the Company's nanoviricide active agent, NV-387, which has shown strong broad-spectrum antiviral activity not only against multiple coronaviruses, but also against RSV and in a model for Smallpox therapeutics.

The Phase 1a Clinical Trial Part, namely Single-Ascending-Dose in Healthy volunteers, Was Completed: The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that all 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending- Dose ("SAD") clinical trial have now completed the study. Follow-up visit was also concluded for all of the Phase 1a volunteers.

Previously, reported on August 21, 2023 that 26 of the 36 healthy volunteers had completed the Phase 1a study. No adverse events or serious adverse events were found at any of the three dose levels studied, in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV- 2 Oral Gummies, in the 26 out of 36 healthy volunteers that had completed the Phase 1b part (Multiple-Ascending Dose) of the study. Additionally, the remaining 10 healthy volunteers have been recruited into the Multiple-AscendingDose part of the Phase 1b study, completing the targeted 36 volunteers recruitment.

The excellent safety of NV-CoV- 2 formulations is expected to enable use of the drug across all patient population, from young children, otherwise healthy persons, to immune-compromised persons, persons with advanced age with or without co-morbidities," said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, "We await completion of the multiple-ascending dose portion of this trial in healthy volunteers which is expected soon. Smallpox poses a significant biodefense threat.ctromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics.ecovirimat is an approved drug for treating smallpox infection based on the FDA " Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic.

The lead drug candidate is NV-CoV-2., that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients. The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.

The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials. NV-CoV-2 is the Company's nanoviricide drug candidate for COVID.

NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc.NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue Viruses, Japanese Encephalitis Virus, West Nile Virus, Ebola/Marburg Viruses, and Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful.

TheraCour has not denied any licenses requested by the Company to date. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.