SHELTON, CONNECTICUT – Thursday, June 20, 2024 -- NanoViricides, Inc. (NYSEAmer.: NNVC) (the "Company"), a clinical stage company and global leader in broad-spectrumantiviral nanomedicines, reports that the ultra-broad-spectrum antiviral NV-387, a clinicalPhase II stage drug candidate, was found to be effective in protecting lungs from damage in alethally infected Influenza A H3N2 mouse model.
"We believe that the lung protection afforded by NV-387 is a very important result. The mostsevere cases that lead to hospitalization and fatalities in respiratory viral infections involve lungdamage as an important factor," said Anil R. Diwan, PhD, President and Executive Chairman ofthe Company, adding, "This was starkly evidenced during COVID-19 pandemic wherein theDelta variant that caused severe lung damage also caused the largest number of hospitalizationsand fatalities. Influenzas, RSV, COVID can all cause severe lung damage resulting in fatalities."1. NV-387 Treatment Resulted in Significant Reduction in Lung Infiltration and Lung Cell DeathLungs of infected animals treated with NV-387, orally or intravenously, showed very limitedpresence of infiltrating cell-killing immune cells that are known to be an important cause of lungdamage, in addition to the direct lung damage from infected cell death caused by the virus itself.Further, the overall lung damage was significantly reduced upon NV-387 treatment.On day 7 post-infection, NV-387 oral treatment resulted in only about 31% lung infiltration byimmune system cells, and NV-387 intravenous treatment resulted in an even lower, about 22%,infiltration rate, whereas the lungs of infected untreated animals had a very high 68% infiltrationrate (smaller is better), as determined by micro-histopathology of lung tissues using specificstaining techniques.
2. NV-387 Treatment Resulted in Significant Reduction in Mucus Load in the LungsAdditionally, the extent of mucus in the lung tissue was substantially reduced in the case of oralas well as intravenous NV-387 treatment. The mucus index value in the case of NV-387 oraltreatment was about 53, and for intravenous NV-387 treatment it was about 32, as compared tothe infected untreated animals that had a mucus index value of 138 (smaller is better).Mucus is secreted by secretory cells in response to viral infection in an attempt to clear the virus,but it results in reduced lung capacity and eventually can lead to pneumonia. Thus reduction inmucus load is an important sign that the progress of the viral infection is arrested.
| NV-387 Treatment Significantly Protected Lungs of Balb-c Mice Lethally Infected with Influenza A/H3N2 Virus |
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| Treatment | Lung Mucus Index | % Immune Cell Infiltration |
| InfiltrationNV-387, Intravenous | 32 | 22% |
| NV-387, Oral | 53 | 31% |
| Untreated Infected Control | 138 | 68% |
These results indicate that NV-387 treatment led to a significant level of protection of lungs inBalb-c mice lethally infected with Influenza A H3N2 virus.
3. NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to ThreeApproved Influenza Drugs
Previously, we reported from this same animal study that NV-387 treatment led to substantiallylonger animal survival compared to the three approved influenza drugs, namely Oseltamivir(Tamiflu ®, Roche), Rapivab (Peramivir, BioCryst), and Baloxavir (Xofluza®, Shionogi, Roche).NV-387 treatment, both intravenous and oral, led to increase in survival of animals by asubstantial 88% over the infected untreated controls, whereas the three approved drugs onlyincreased survival marginally, by about 25% to 38%. These results indicate that NV-387 wassubstantially superior to the three approved influenza drugs in this animal study.
The above results demonstrate that NV-387 possesses strong antiviral activity against Influenzaviruses.
4. Viral Resistance to NV-387 is Unlikely as Opposed to Known Evolution of Viral ResistanceAgainst Currently Approved DrugsBaloxavir resistant mutants were found to develop in as many as 10% of treated patients in itsPhase III clinical trials. Oseltamivir resistant mutants are known and circulating, and they exhibitresistance to Peramivir as well.
In contrast, even as influenza viruses mutate, they would be highly unlikely to escape NV-387.This is because NV-387 is an ultra broad-spectrum antiviral that is designed as a host-mimetic(See paragraph (a) below).
5. NV-387 Has Completed Phase I Human Clinical Trial
There were no reported adverse events, and there were no dropouts in the Phase 1 human clinicaltrial of NV-387, indicative of excellent safety and tolerability of NV-387. This drug candidate isthus ready for further development in Phase II clinical trials.
In summary, NV-387 is poised to become a very important drug in the fight against Influenzaviruses, we believe.
(a). Host-Mimetic Nanoviricide Drug Candidate NV-387 is Designed to Attack Many Viruses;with Escape of Virus Unlikely
All influenza viruses bind to the host's sulfated proteoglycans ("S-PG") as primary attachmentreceptors and cellular sialic acids as cognate receptors; the latter enabling entry into cells. NV-387is designed to copy the invariant or conserved features of S-PG and present itself like a humancell decoy to the virus. As the virus binds to the NV-387 metamorphic ("shape-shifter") micelle,the NV-387 polymer chains are expected to wrap onto the virus surface, via a well known processcalled "lipid-lipid fusion", merging the lipid chains of the NV-387 polymer with the lipid coat ofthe virus particle. This is expected to result in destabilization of the virus, uprooting the H and Nproteins from the virus surface, thereby making the virus incapable of attacking human cells.A safe and effective antiviral drug that the virus would not escape by simple mutations or fieldevolution is the holy grail of antiviral drug development. We believe that the NanoViricidesPlatform technology meets this challenge.About NanoViricides
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage companythat 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 for the treatment of RSV, COVID-19, Long COVID, and otherrespiratory 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 forany of its drugs because of dependence on a number of external collaborators and consultants. TheCompany is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.NV-CoV-2 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-CoV-2 with remdesivirencapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDAapproved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety iscomparable. Remdesivir is developed by Gilead. The Company has developed both of its own drugcandidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including oral andgenital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 birdflu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technologyof TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusiveperpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity forthe 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 Encephalitisvirus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtaina license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technologyis based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas fromTheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCourPharma 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 developmentof any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drugdevelopment efforts by any company, there can be no assurance at this time that any of the Company'spharmaceutical 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 leadto successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's currentexpectation regarding future events. Actual events could differ materially and substantially from thoseprojected herein and depend on a number of factors. Certain statements in this release, and other written ororal statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning ofSection 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Youshould not place undue reliance on forward-looking statements since they involve known and unknownrisks, uncertainties and other factors which are, in some cases, beyond the Company's control and whichcould, and likely will, materially affect actual results, levels of activity, performance or achievements. TheCompany assumes no obligation to publicly update or revise these forward-looking statements for anyreason, or to update the reasons actual results could differ materially from those anticipated in theseforward-looking statements, even if new information becomes available in the future. Important factors thatcould cause actual results to differ materially from the company's expectations include, but are not limitedto, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed bythe company from time to time with the United States Securities and Exchange Commission and otherregulatory authorities. Although it is not possible to predict or identify all such factors, they may includethe following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe andeffective; successful development of our product candidates; our ability to seek and obtain regulatoryapprovals, including with respect to the indications we are seeking; the successful commercialization of ourproduct candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer toresearch findings including clinical trials as the customary research usage and do not indicate evaluation ofsafety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational NewDrug" 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, whichis the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for"Active Pharmaceutical Ingredient".Contact:!
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR !clyburn@tradigitalir.com
Source: NanoViricides, Inc.