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By David Willey, Benzinga
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Effective treatments for COVID-19 remain very few and verylimited in their capabilities, even after three years. As a result,there are still high rates of hospitalizations and COVID remains many times more deadly than influenza. A pan-coronavirus drug that issafe enough to be used by anyone and is highly effective remains anunmet medical need.
NanoViricides Inc. (NYSEAMERICAN: NNVC), a leadingbiopharmaceutical company developing nanotechnology-based antiviraltherapeutics, has been working on a pan-coronavirus antiviral tofulfill this unmet medical need. The company has been a drug discoverycompany for many years while it has looked to perfect its patentednanoviricide technology, a platform technology that deploys a novelmechanism to combat viruses. With this unique technology, the Companyhas reported developing a strong R&D pipeline of many antiviraldrugs.
NanoViricides is now excited tobe transitioning into becoming a clinical-stage pharmaceuticalcompany, and with a drug against COVID. The clinical trials ofNV-CoV-2, the Company’s pan-coronavirus drug, are now imminent .The drug has already successfully completed the preclinical safety and effectiveness studies, and the Company hasalready set up cGMP manufacturing for the clinical drug products.
NanoViricides Drug To Work Against All Current and FutureCOVID Variants?
NV-CoV-2 is a broad-spectrum antiviral that looks to treat mosthuman coronaviruses and will maintain its effectiveness as thevariants mutate. This may mark a major step in the fight to find apermanent solution to COVID. Developing a drug that works againstmultiple COVID variants is key because as each variant mutates andspreads it has the risk of further widespread outbreaks causing an endemic or even a futurepandemic.
Despitethe rollout of the vaccine from companies including Novavax Inc. (NASDAQ: NVAX), Moderna Inc. (NASDAQ: MRNA), AstraZeneca (NASDAQ: AZN), and Pfizer Inc. (NYSE: PFE), there are still over 170,000 infections weekly, as well as close to 3,000 hospitalizationsand 1,800 deaths in the USA alone. COVID is still the biggest viralpublic health threat today.
In the ongoing fight against the virus, one majorbattle is of coping with the multiple coronaviruses and the continuousevolution of their variants .In addition to SARS-CoV-2 and its variants, there are already fourknown seasonal human coronaviruses, hCoV-229E, hCoV-OC43, hCoV-HKU1,and hCoV-NL63, with NL63 causing the most similar symptoms toSARS-CoV-2. Any of these can lead to a more pathogenic variant in thenear future. As these viruses continue to mutate, they renderantibodies developed against previous strains ineffective. This meanseven so-called “ hybridimmunity ”– natural protection combined with vaccination– often only lasts for around eight months.
It is important to notethat all of the antibody drugs that were given emergency useauthorizations (EUAs) have had the EUAs revoked upon becomingineffective.
NV-CoV-2 was found towork against many unrelated coronaviruses. So variants of SARS-CoV-2(that causes COVID) are highly unlikely to be able to escape it.
NanoViricides Drug NV-CoV-2 Could Cater To The Needs of AllPatients
Antiviral medication is an important way of coping with viralinfections, other than vaccines and antibodies, as we all know fromHIV. These drugs help the body fightoff infection at the cellular level. However, there aresignificant issues with the antivirals currently on the marketfor
treating COVID. These include Molnupiravir from Merck & Co. (NYSE: MRK), Paxlovid from Pfizer Inc. (NYSE: PFE) and Remdesivir from Gilead Sciences, Inc. (NASDAQ: GILD), which either havelimited effectiveness in treating the disease or carry the risk ofserious side effects or both. Of note, they all have significantlimitations on which category of patients can be helped.
Unlike the existingCOVID drugs, NanoViricides’ drug NV-CoV-2 caters to the needs of allpatients. The Company has developed oral syrup and oral gummies foruse in mild to moderate disease (out-patients). It has developed aninjectable solution that can be injected, inhaled or infused, for usein severely ill or hospitalized patients. Having these multipleformulations gives the drug a broad range of applications; it would beavailable to patients with or without comorbidities and patients ofall ages from a child to an octa(+)genarian. This unmatched useabilityis driven by its demonstrated strong safety and effectiveness inpreclinical studies.
The company alsohas the ability to manufacture clinical quantities of the drugproducts for clinical trials in its own “current Good ManufacturingPractices (cGMP)”-compliant facility, enabling time and costsavings.
NanoViricides At An Inflection Point In ItsLifecycle?
Thecompany’s clinical trials could be ground-breaking — a novelanti-coronavirus drug, and the possibility for the trials to alsoprove that the Company’s platform is indeed capable of deliveringclinical drugs. There is a whole pipeline of preclinical drugs thatthe Company intends to advance further.
The global antiviral market was worth $48.1 billion in 2018 and is expected to grow to $79.8 billion at acompound annual growth rate (CAGR) of 6.7% from 2019 to 2026.
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This article wasoriginally published on Benzinga here .
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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