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Monday, January 29, 2024

NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2: No Adverse Events Found

 NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the healthy subjects part of the Phase 1a/1b Clinical Trial of NV-CoV-2 was completed successfully. No adverse events were reported in any of the multiple ascending dose cohorts, confirming the excellent safety of NV-387, the active ingredient in NV-CoV-2.

NV-387 is highly active against many respiratory viruses; all tested Coronaviruses and RSV among them. NV-387 was designed to mimic the host-side feature called "sulfated proteoglycans" ("S-PG"), presenting a biomimetic of S-PG on the surface of the nanoviricide that mimics a biological cell membrane. Over 90% of human pathogenic viruses use S-PG receptors to cause infection, and many of them are expected to be susceptible to NV-387.

NV-387 is designed to attack the viral surface and disable the virus from being able to infect cells. This is reminiscent of how antibiotics such as penicillins attack bacterial surface and dismantle the bacteria.

This ultra-broad-spectrum, cross-virus-families, antiviral activity of NV-387 is expected to revolutionize not only the treatment of viral infections but also how we respond to potential pandemics in a significantly more rapid fashion than what happened with COVID-19.

Viral variants are unlikely to escape the nanoviricide drug (i) because even as the virus mutates it still binds to the same host-side features, that the nanoviricide copies; and (ii) such escape is not expected based on the extremely wide spectrum of activity of NV-387, across multiple viruses in each family and across distinct virus families.

All clinical trial subjects were held in the hospital during treatment period. All of them have been discharged and all of them have also gone through the final post-discharge follow-up visit. There were no adverse events reported during treatment or through the follow-up visit. Clinical observations during the in-hospital sequestration did not show any adverse events. No adverse events were reported from lab reports of the subjects for various blood tests, organ function tests, or ECG (heart). There were no dropouts.

These results are indicative of an excellent safety profile of NV-387. These results are consistent with the excellent safety characteristics observed for NV-387 in the pre-clinical studies.

NV-387 has been found to be non-immunogenic, non-allergenic, non-mutagenic, as well as non-genotoxic in various pre-clinical animal model studies leading to the clinical trials. No adverse effects were reported in GLP Safety-Toxicology studies in multiple animal models including non-human primates (NHP, Cynomolgus monkeys). The NOAEL (No-Observed-Adverse-Events-Level) was 1,200 mg/Kg and MTD (Maximum Tolerable Dose) was 1,500 mg/Kg in rats, which indicate excellent safety.

In contrast, most known antiviral drugs have significant dose-limiting toxicities.

https://www.accesswire.com/828857/safety-in-multiple-ascending-dose-healthy-subjects-clinical-trial-part-successfully-established-for-the-nanoviricides-ultra-broad-spectrum-antiviral-drug-nv-cov-2-with-no-adverse-events-found

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