NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon

SHELTON, CT / ACCESSWIRE / April 30, 2024 / NanoViricides, Inc. (NYSE Amer:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that the Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon.

The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed and completed in April by the Drug Sponsor and our licensee, Karveer Meditech, Pvt. Ltd., and the CRO, PristynCR, in India. The decision to close the clinical trial with healthy subjects study completed was taken because diligent efforts to identify suitable COVID-19 participants for the clinical trials were met with a notable absence of positive cases at the designated clinical trial sites, despite addition of a second site during January/February 2024.

Both the single ascending dose part of this clinical trial (called Phase 1a), and the subsequent multiple ascending dose part (called Phase 1b) have been completed with healthy subjects. There were no reported adverse effects, indicating excellent safety of both of the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, at all of the dosage levels given to the subjects. The CRO is now in the process of completing database input of all of the subjects' clinical datasets to achieve datalock for further statistical analysis.

Phase II Clinical Protocol Discussion in Progress

As previously reported, NV-387, the active ingredient in the drug products in this clinical trial, has been demonstrated to possess an extremely broad effectiveness against multiple virus families in lethal animal studies evaluating NV-387 in comparison to available drugs. Thus, NV-387 has been found to be active against (i) Coronavirus infection, (ii) RSV infection, and (iii) Smallpox/Mpox related Ectromelia virus infection in animal models.

This ultra-broad-spectrum activity profile of NV-387 in animal models suggests that it could be a single drug effective against most if not all of the respiratory viral infections.

We have therefore initiated discussions with physicians, subject matter experts, and clinical site investigators in India, towards designing appropriate clinical trials for determining the dosing protocol and effectiveness of NV-387 towards the goal of clinically establishing the spectrum of effectiveness of NV-387. An antiviral drug such as NV-387 if found to be effective in human clinical studies would be a highly desirable drug globally. It would enable treatment of patient as soon as they present to the physician with a viral disease without waiting for a test for identifying which viral infection it is. This is reminiscent of how antibiotics are prescribed, without specific infectious agent identification, relying on the ultra-broad-spectrum of antibacterial activity.