Benzinga | Feb 8, 2021 06:19AM EST

NanoViricides's Broad-Spectrum Antiviral Drug Candidate for the Treatment of COVID-19 Infections was Well Tolerated in GLP and non-GLP Animal Safety Studies

NanoViricides, Inc. (NYSE:NNVC) (the "Company") a global leader in the development of highly effective broad-spectrum antiviral therapies based on a novel nanomedicines platform has announced today that its broad-spectrum anti-coronavirus drug candidate for the treatment of COVID-19 infections was well tolerated in safety pharmacology studies required for progressing to human clinical trials.

The Company reports that its drug candidate NV-CoV-2 was found to be safe in the GLP safety pharmacology studies performed by an external contract research organization (CRO) in both rat and non-human primate (NHP) models. Additionally, multiple injections of NV-CoV-2 were also well tolerated in an extensive non-GLP study in rats that was performed by AR Biosystems, Inc., FL.

Based on the safety of NV-CoV-2 in these studies, the Company believes that projected dosages would be safe in human clinical trials. With these findings, the Company believes that it will be possible to administer repeated dosages of NV-CoV-2 in a human clinical trial, if needed, to achieve control over the coronavirus infection from SARS-CoV-2 or its variants.

In a GLP neuro-pulmonary safety pharmacology study in rats, the following conclusion was drawn: The intravenous administration of NV-CoV-2 at doses of 25, 50 and 100 mg/kg did not affect respiratory function in rats.

In a GLP cardiovascular function study in the NHP cynomolgus monkeys, the following conclusion was drawn: Intravenous infusion of NV-CoV-2 at 25, 37.5, and 50 mg/kg did not have any toxicologic effects on cardiac rhythm or ECG morphology in cynomolgus monkeys in this study. No significant effects on blood pressure and heart rate were observed after the intravenous infusion of NV-CoV-2.

These results were consistent with a more extensive, multiple injection non-GLP safety and tolerability study in Sprague-Dawley male and female rats. In this non-GLP study, NV-CoV-2 was injected intravenously (via tail vein) on each of days 0, 1, 2, 3, 4, and 5. Two different doses were used: 320mg/kg BW per injection, and 160 mg/kg BW per injection. Clinical observations, body weight, urine, blood chemistry, post-mortem findings, and organ histology were studied. In all parameters, NV-CoV-2 was well tolerated at both dosages throughout the study.

The Company has received draft reports from all of these studies. We anticipate receiving final audited reports on the GLP studies shortly.

The Company is preparing to submit a pre-IND application to the US FDA with safety tolerability and effectiveness data to obtain guidance regarding human clinical trials. Additionally, we are actively seeking opportunities to engage appropriate sites for human clinical trials. Further, we are engaged in the preparation of clinical trial protocols and other activities that would be necessary for submitting an IND application to the US FDA.

The need for the broad-spectrum, pan-coronavirus nanoviricide drug treatment cannot be overstated for combating the COVID-19 pandemic given the current circumstances and the present status of the pandemic. New virus variants continue to develop in the field. The variants that have advantages in terms of transmissibility, infectivity, and escape from drugs and vaccines will continue to evolve and spread, replacing prior variants. This is already well documented.

Several vaccines have been found to be substantially less effective in protecting against infection by the South African variant, N501Y-V.2 (also called lineage B.1.351) than the earlier variants. A mutation present in B.1.351 as well as Brazilian variant P.1 that is thought to be possibly linked to evasion from antibody drugs and vaccines, E484K, has also been reported in UK in a further differentiated mutant of the variant of concern lineage B.1.1.7. The available monoclonal antibody drugs and convalescent plasma antibodies have been reported to be less effective against several variants.

By the very nature of how they work, vaccines and antibodies tend to be highly specific to the target virus variant, and do not afford strong protection against differentiated variants that are evolutionary distant from the target variant. This scientific fact is now well demonstrated for the COVID-19 pandemic.

It is therefore clear that an effective broad-spectrum anti-coronavirus drug will be needed before the world can return to normal activity.

The Company previously had advanced NV-CoV-1 and had continued to work further with additional drug candidates. One of these drug candidates, namely, NV-CoV-2 was found to have several advantages over NV-CoV-1 in terms of manufacturability and dose formulation. Therefore the Company has advanced NV-CoV-2 into GLP safety/pharmacology studies.

NanoViricides is developing a broad-spectrum antiviral drug where the potential for escape of virus variants is minimized by the very design of the drug for the treatment of COVID-19 infected sick persons. In contrast, vaccines are not treatments for sick persons, and must be administered to healthy individuals, and further require several weeks for the recipient's immune system to become capable of protecting against the target virus strain which still may not protect against new virus variants circulating by that time.

NanoViricides has a strong advantage in that the Company has its own cGMP-capable manufacturing facility in Shelton, CT. This facility is capable of producing approximately 4kg of the COVID-19 drug per batch. We anticipate that this would be sufficient for human clinical trials, and possibly for initial introduction under Compassionate Use, Emergency Use Authorization or similar regulatory approval.

"We are pleased with the results of the safety pharmacology studies, and now we are confident that our COVID-19 drug candidate can advance into human clinical trials," said Anil R. Diwan, PhD, President and co-Founder of NanoViricides, Inc., and co-Inventor of its platform technologies and drug candidates.