COVID is Here to Stay and NV-387 is a Much Needed Drug Against It, Reminds NanoViricides
SHELTON, CT / ACCESSWIRE / July 24, 2024 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, today reminds the strong safety and effectiveness against coronaviruses demonstrated by its lead clinical drug candidate NV-387.
"President Joe Biden has thankfully recovered from the bout of COVID caused by a new variant," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This again brings into limelight the lack of strong drugs against COVID; a gap that NV-387 is expected to fulfill."
There is clearly a need for a highly effective and preferably oral drug against COVID. COVID in the USA has become a biannual affair, with ever new, different variants leading each new wave. COVID continues to claim annually greater numbers of lives and hospitalizations than Influenza.
We believe it is important to bring to the attention of everyone how strong the activity of NV-387 in animal studies against coronaviruses has been, even compared with the most effective anti-coronavirus drug, namely, remdesivir (Veklury® Gilead).
We have studied a lethal lung infection in rats with a coronavirus that results in the same pathology but only milder than the delta variant, in humans as compared to COVID.
In one study, NV-387 intravenous injection (I.V.) treatment led to a substantial improvement in survival, of 180%, as compared to Remdesivir, of only 50%, as shown in the Table below.
Survival Lifespan of Lethally Infected Rats - Lung Infection with hCoV-NL63 | |||
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % |
NV-387, I.V. | 14 | 9 | 180% |
Remdesivir, I.V. (Veklury formulation) | 7.5 | 2.5 | 50% |
Vehicle; Untreated | 5 | 0 | - |
We thereafter developed an oral formulation of NV-387 and studied its effect in comparison to the NV-387 I.V. treatment. The results are shown in the Table below:
Survival Lifespan of Lethally Infected Rats - Lung Infection with hCoV-NL63 | |||
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % |
NV-387, I.V. | 16.6 | 8.9 | 116% |
Vehicle Control for I.V. | 7.7 | 0 | - |
NV-387, Oral | 12.8 | 6 | 88% |
Vehicle Control for Oral | 6.8 | 0 | - |
These results indicate that NV-387 oral drug is expected to be highly effective in treatment of COVID infections. The results also suggest that for hospitalized patients, NV-387 injectable form would be preferable over the oral form.
The focus throughout the pandemic has been primarily on antibodies and vaccines. Antibodies as drugs are now clearly evidenced to be not useful for a long enough period to provide major public health benefits. The limits of vaccines and vaccination campaigns both have also become clearly evident. In this scenario, Paxlovid™ (Pfizer) remains the only oral drug available, in spite of its known weak clinical effectiveness, which is evidenced in clinical trials that showed that in otherwise healthy adults it was not shown to be better than placebo.
Additional drug development for COVID treatment is clearly a public health necessity. NV-387 is possibly the most advanced drug candidate that has demonstrated both strong activity and safety in a number of studies towards regulatory approvals.
NV-387 has undergone Phase I human clinical trial to evaluate the safety and tolerability in the form of two different oral formulations, namely, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies in India. There were no dropouts and there were no reported adverse events, indicating excellent safety and tolerability of NV-387 even at high dosage levels.
We have also found that NV-387 has a very wide antiviral spectrum, covering at least the following: Coronaviruses, RSV, Influenza, and Poxviruses (Smallpox/Mpox). This indicates that antiviral drug resistance against NV-387 would be highly unlikely.
We are now seeking collaborations with Pharma companies to bring this remarkable drug, NV-387, towards regulatory approvals for multiple antiviral indications.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development 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-387 for the treatment of RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. 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 drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity 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 certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. 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.
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 for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
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 which are, in some cases, beyond the Company's control and which 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.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient".
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SOURCE: NanoViricides, Inc.
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