The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides
6:41 AM ET 11/28/23 | Dow Jones
SHELTON, CT / ACCESSWIRE / November 28, 2023 / 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 Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully. Recruitment for the Multiple-Ascending Dose part was also completed. The drug NV-CoV-2 contains the Company's nanoviricide active agent, NV-387, which has shown strong broad-spectrum antiviral activity not only against multiple coronaviruses, but also against RSV and in a model for Smallpox therapeutics.
The Phase 1a Clinical Trial Part, namely Single-Ascending-Dose in Healthy Volunteers, Was Completed Successfully:
The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that all 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose ("SAD") clinical trial have now completed the study. Follow-up visit was also concluded for all of the Phase 1a volunteers. Previously, we reported on August 21, 2023 that 26 of the 36 healthy volunteers had completed the Phase 1a study.
No Adverse Events Found in the Healthy Volunteers Cohorts to Date:
No adverse events or serious adverse events were found at any of the three dose levels studied, in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the completed Phase 1a (Single Ascending Dose) part of the study.
To note, we have previously reported that no adverse events or serious adverse events were found in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the 26 out of 36 healthy volunteers that had completed the Phase 1b part (Multiple-Ascending Dose) of the study.
Recruitment for Multiple-Ascending-Dose Clinical Trial (Phase 1b) in Healthy Volunteers Was Completed:
Additionally, the remaining 10 healthy volunteers have been recruited into the Multiple-Ascending Dose part of the Phase 1b study, completing the targeted 36 volunteers recruitment.
"The excellent safety of NV-CoV-2 formulations is expected to enable use of the drug across all patient population, from young children, otherwise healthy persons, to immune-compromised persons, persons with advanced age with or without co-morbidities," said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, "We await completion of the multiple-ascending dose portion of this trial in healthy volunteers which is expected soon. Thereafter we plan on advancing NV-387 for the treatment of several different viruses that this drug has shown strong activity against."
NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families:
NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. 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.
The market size for RSV therapeutics has been estimated to be approximately $2 Billion rising to $8 Billion.
Additionally, we recently reported that NV-387 was as effective as the approved drug tecovitrimat (TPOXX(R), SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism.
Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic. It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.
NV-387 Acts by a Novel Mechanism:
We developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is 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 the virus incapable of infecting another cell.
We call this novel antiviral mechanism "Re-Infection Blocker".
NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria:
In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, we anticipate that NV-387 may have effectiveness against many other viruses. We plan on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications.
NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.
NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats:
There is a significant unmet medical need for a broad-spectrum antiviral 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.
We believe that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.
NV-387 Addresses Large Market Sizes:
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.
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(R) 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.
The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.
The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.
The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue Viruses, Japanese Encephalitis Virus, West Nile Virus, Ebola/Marburg Viruses, and Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Disclosure Statement
2023-11-28 11:41:00 GMT The Phase 1a/1b Human Clinical Trial of NV-CoV-2, -2-
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. In particular, as is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
CONTACT:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
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