NanoViricides Announces that Clinical Trials of Its Broad-Spectrum Antiviral Drug NV-CoV-2 Have Begun

SHELTON, CT / ACCESSWIRE / June 29, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") reports that clinical trials of its broad-spectrum antiviral drug NV-CoV-2 began on June 17, 2023 with two oral drug products: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies.

 

"We believe that the start of the Phase 1a/1b safety and efficacy clinical trial is an important milestone not only for NanoViricides and Karveer Meditech, India, but for the whole world," said Dr. Anil Diwan, Ph.D., President and Executive Chairman of the Company, explaining, "NV-CoV-2 is aimed at satisfying the as-yet-unmet medical need for a highly effective broad-spectrum, pan-coronavirus drug that can be used for all patient populations. Further, we believe the nanoviricides technology adds a valuable tool to the basket of worldwide preparedness and response strategies for future viral pandemics."

 

The Company is a clinical-stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, called "nanoviricides". NV-CoV-2, the Company's lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, has now entered Phase 1a/1b human clinical trials that are sponsored by Karveer Meditech Pvt. Ltd. India, the Company's Licensee and co-developer in India (see below).

 

The Clinical Trial Will Evaluate Both Safety and Initial Efficacy Indications in COVID patients:

 

Phase 1a will assess the safety and tolerability of a new molecule (drug product NV-CoV-2 containing API NV-387) in healthy subjects. In Phase 1b, patients with mild to moderate COVID-19 will be enrolled to assess indication of efficacy.

 

The Single Dosing of Healthy Volunteers portion of the Phase 1a began with the dosing of a first set of volunteers on June 17, 2023. This set of volunteers was successfully discharged after a 48 hours in-hospital stay for observation, and will be further assessed in a final out-person visit as per the protocol. Further recruitments and dosings are scheduled as per the protocol.

 

NV-387 Is a First-in-Class Chemical Nanomachine that Acts by a Novel Mechanism of Action:

 

The Company calls the antiviral mechanism of NV-387 "Re-Infection Blocker." The drug is designed to directly attack the virus particle with a multi-pronged attack and thereby disable the virus completely so that it cannot further infect human cells and the infection cannot progress. The Company believes that this novel antiviral mechanism can become an important new tool for worldwide pandemic preparedness and response strategies to combat future viral pandemics.