Shelton - 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 Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, is progressing successfully.

Healthy Volunteers Recruitment for Phase 1a and Phase 1b is Progressing Satisfactorily: The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that approximately 26 out of the target of 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose ('SAD') have already completed the study. Additionally, 17 out of the target of 36 healthy volunteers in the various cohorts in the Phase 1b Multiple-Ascending-Dose ('MAD') part of the clinical trial have already completed the study.

No Adverse Events Found in the Healthy Volunteers Cohorts to Date

No adverse events or serious adverse events were found in the SAD or MAD studies to date, in either the NV-CoV-2 Oral Syrup or the NV-CoV-2 Oral Gummies administration cohorts.

Recruitment in COVID Patient Treatment Part of Phase 1b to Begin Soon

The CRO, PristynCR, India, has advised us that they have requested approval from the Ethics Committee to begin recruitment into the Phase 1b COVID Patient Treatment part of the clinical trial, based on the excellent safety and tolerability of the drug.

The Phase 1b Part of Treatment of COVID Patients is designed to provide initial indications of effectiveness and dose requirements.

'NV-CoV-2 can be expected to be a game-changing broad-spectrum antiviral if its effectiveness in the COVID patients in this clinical trial demonstrates results consistent with the observed extremely strong effectiveness in pre-clinical animal studies,' said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, 'The excellent safety and tolerability of NV-CoV-2 in both formulations in the clinical trials is consistent with the results of pre-clinical animal studies, giving us confidence that our pre-clinical animal studies can be expected to be predictive of human clinical trials.'

COVID Virus Continues to Mutate, Posing a Strong and Continued Threat:

SARS-CoV-2 virus continues to mutate unabated, generating new variants much faster than vaccines can be developed, and the possibility of a severely pathogenic variant similar to the delta variant remains. The WHO began monitoring BA.2.86 as a new 'variant under monitoring' because it carries more than 30 mutations over its parent of lineage BA.2, and because it has already been found in four distant parts of the globe (https://www.who.int/activities/tracking-SARS-CoV-2-variants). While EG.5 is currently the dominant COVID variant in the USA, it is likely to be replaced by BA.2.86.

Dr. Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, said it's too soon to tell how much protection the new vaccine shots could provide against BA.2.86, but the variant is 'not a good match' for the updated boosters, according to NBC News (https://www.nbcnews.com/health/health-news/cdc-monitoring-new-covid-variant-cases-guidance-rcna100613).

COVID waves are expected to continue because of novel variants appearing constantly. However, with the built-up immunity from prior SARS-CoV-2 exposures and infections with several variants, as well as the earlier vaccinations, the fatality rates are expected to remain low.

Nevertheless, the COVID waves continue to cause an adverse economic impact worldwide that is substantially greater than that caused by influenza viruses.

NV-CoV-2 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug Against Multiple Viral Threats:

There is a significant unmet medical need for a broad-spectrum anti-coronavirus drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug. The Company believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 support the use of this drug across all patient populations.

Additionally, NV-387, the active pharmaceutical ingredient ('API') of NV-CoV-2 has demonstrated strong antiviral activity against lethal lung infection by RSV in pre-clinical studies. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.

There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity.

Phase 2 Human Clinical Trials Towards Multiple Viral Threats

The Company believes that subsequent to the completion of this Phase 1a/1b clinical trial, it will be able to seek permission from multiple regulatory agencies to conduct Phase 2 clinical trials for the treatment of at least COVID and RSV.

Strong Market Sizes Addressed by NV-CoV-2

In addition to the well-known strong and continuing market size for COVID drugs, GrowthPlus Reports, in June 2023, has said that the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.

NV-387 Acts by a Novel Mechanism

The Company developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It was designed to 'look like a cell' to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering it incapable of infecting another cell.

The Company calls this novel antiviral mechanism 'Re-Infection Blocker'.

Expanding Indications of NV-387

NV-387 employs mimics of well known attachment sites on the cells commonly used by viruses called sulfated proteoglycans. Since these attachment receptors are used by over 90% of human pathogenic viruses, the Company anticipated that NV-387 may have effectiveness against many viruses beyond coronaviruses, our initial focus.

RSV is the first non-coronavirus that the Company has evaluated for susceptibility to NV-387. The Company plans to pursue exploration of activity of NV-387 against additional viruses to further expand its spectrum of applicability.

About NanoViricides

NanoViricides, Inc. (the 'Company') (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our 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.

Contact:

Email: info@nanoviricides.com

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