(NewsDirect)
By David Willey, Benzinga
Read the latestreport on NanoViricides here .
SARS-CoV-2 is not doneyet — Although it is not grabbing as many headlines, the number ofdeaths are still greater than even a pandemic influenza year at lastcount. The virus is still lurking, causing COVID and long COVID.Former White House COVID czar AshishJha has said “There is a temptation to say it's all overand we don't have to think about COVID anymore. The way I look atit is the virus can still surprise us.”
We have learnt just to live with it, thanks tothe immunity from vaccines and from the viral infection itself.However, according to the WorldHealth Organization (WHO) , “Even in vaccinated individuals,uncertainties remain about the duration of protection, theeffectiveness of current vaccines and the efficacy of existingtreatments for COVID-19 against emerging SARS-CoV-2 variants andsubvariants.” Despite over 300 clinical trials, there are only threeapproved drugs that remain. Unfortunately, each of them haslimitations.
Current Approved Therapies Have SignificantLimitations
Remdesivir, from Gilead Sciences (NASDAQ:GILD) has only received a conditional recommendation from the WHO forpatients with severe COVID-19. Also, Remdesivir can only beadministered as an infusion in a hospital, limiting the patientpopulations who can get access to the drug.
Two other drugs,Molnupiravir by Merck & Co. (NYSE: MRK) and Paxlovid by Pfizer (NYSE: PFE) are both orally available. The WHO hasissued a strong recommendation for Paxlovid, but only a conditionalrecommendation for Molnupivavir for patients with severe COVID-19 ornon-severe COVID-19 at the highest risk of hospitalization.
However, the WHO noteslimitations to both of these drugs in its guidelines, and it alsodoesn’t advise certain populations to take these treatments onaccount of drug-to-drug interactions or other side effects.
This indicates a needfor a safer and more comprehensive treatment. A unique and novel drugthat looks to fulfill this unmet medical need is NV-CoV-2, developedby NanoViricides, Inc. (NYSE American: NNVC).
NanoViricides recentlyannounced it has begun clinical trials for NV-CoV-2, an innovativetreatment for patients with COVID-19. NanoViricides is developing anovel nanomedicine platform of antiviral therapies, and itsleading drug candidate is NV-CoV-2, which contains API NV-387.
Dr. Anil Diwan,President and CEO of NanoViricides, described the drug as an excitingopportunity to fill an “as-yet-unmet medical need of a highlyeffective broad-spectrum, anti-coronavirus drug that can be used forall patient populations.”
The drug has already demonstrated a robust safetyprofile in pre-clinical animal safety and tolerability evaluations, aswell as showing itself to be non-immunogenic and non-mutagenic instandard tests.
These data suggest a potentially exciting feature of NV-CoV-2in its ability to treat all patient populations.
Now with the trialbeginning, its primary outcomes include: “To evaluate the safety andtolerability with the initial administration of NV-CoV-2 in healthyhuman subjects,” and “To find the maximum tolerated dose for thesupport of phase-2 clinical trials.”
It employs NV-387, a first-in-class chemicalnanomedicine with a novel mechanism of action called the“Re-Infection Blocker” designed to entirely eliminate the virusfrom the patient’s system.
The drug will be trialed on patients with mild tomoderate COVID-19, in the Phase 1b part of the clinical trial, thoughthe company believes this could also be efficacious for patients withsevere coronavirus and even for hospitalized cases. Note that NV-CoV-2has been shown to be significantly more effective than Remdesivir inlethal lung infection models of human coronavirus NL-63 in rodents.Remdesivir is the only drug currently approved for hospitalized cases.
There aremultiple formulations of NV-CoV-2, including as an oral syrup and oralgummy, for outpatient use, which broadens the patient population thatcould take this treatment. An injectable formulation was alsodeveloped for hospitalized patients.
NanoViricides believes that the safety and efficacyof this drug could make it a popular choice, as some of the morepopular alternative COVID-19 treatments available are either less safeor are contra-indicated for several classes of patients.
According toNanoViricides, this opens up a huge market for its drug, NV-CoV-2. Asa broad-spectrum anti-coronavirus drug with multiple formulations, itcan be given to any patient group. Plus, its novel nanomedicinetechnology potentially makes it a highly effective treatment forCOVID-19 as well as other coronaviruses .
Learn more about howNanoViricides is tackling different viruses byvisiting its website .
AboutNanoViricides
NanoViricides, Inc. (the "Company")(www.nanoviricides.com) is a development stage company that iscreating special purpose nanomaterials for antiviral therapy. TheCompany's novel nanoviricide® class of drug candidates aredesigned to specifically attack enveloped virus particles and todismantle them. Our lead drug candidate is NV-HHV-101 with its firstindication as dermal topical cream for the treatment of shingles rash.In addition, we are developing a clinical candidate for the treatmentof COVID-19 disease caused by SARS-CoV-2 coronavirus. The Companycannot project an exact date for filing an IND for this drug becauseof its dependence on a number of external collaborators andconsultants.The Company is now working on tasks for completing an INDapplication. The Company is currently pursuing two separate drugcandidates for the treatment of COVID-19 patients. NV-CoV-2 is ournanoviricide drug candidate that does not encapsulate Remdesivir.NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2with Remdesivir encapsulated in it. The Company believes that sinceRemdesivir is already US FDA approved, our drug candidateencapsulating Remdesivir is likely to be an approvable drug, if safetyis comparable. Remdesivir is developed by Gilead. The Company hasdeveloped both of its own drug candidates NV-CoV-2 and NV-CoV-2-Rindependently.The Company intends to re-engage into an IND applicationto the US FDA for NV-HHV-101 drug candidate for the treatment ofshingles once its COVID-19 project moves into clinical trials, basedon resources availability. The NV-HHV-101 program was slowed downbecause of the effects of recent COVID-19 restrictions, andre-prioritization for COVID-19 drug development work.The Company isalso developing drugs against a number of viral diseases includingoral and genital Herpes, viral diseases of the eye including EKC andherpes 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 theTheraCour® nanomedicine technology of TheraCour, which TheraCourlicenses from AllExcel. NanoViricides holds a worldwide exclusiveperpetual license to this technology for several drugs with specifictargeting mechanisms in perpetuity for the treatment of the followinghuman viral diseases: Human Immunodeficiency Virus (HIV/AIDS),Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, HerpesSimplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),Influenza and Asian Bird Flu Virus, Dengue viruses, JapaneseEncephalitis virus, West Nile Virus, Ebola/Marburg viruses, andcertain Coronaviruses. The Company intends to obtain a license forpoxviruses if the initial research is successful. The Company'stechnology is based on broad, exclusive, sub-licensable, fieldlicenses to drugs developed in these areas from TheraCour Pharma, Inc.The Company's business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specificviruses, as established at its foundation in 2005.
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