(NewsDirect)
By David Willey, Benzinga
Read the latestreport on NanoViricides here .
NanoViricides (NYSE American: NNVC) has begun trials for its new drug candidate,NV-CoV-2 — an exciting development for the biotech company, as itstarts its first human trials with drug sponsor Karveer Meditech Pvt.Ltd. India, the company’s licensee and co-developer in India.
NanoViricides has been buildingout a novel nanomedicine platform for many years, and thisplatform now includes a pipeline of multiple preclinical antiviraldrugs. The Company is developing antiviral medications that are builton the company’s patented nanoviricide technology. Nanomedicine hasa lot of promise, but thereare almost no nanomedicines available on the market to treatviral infections. Because of prior acquired expertise,NanoViricides’ first-in-class COVID drug, NV-CoV-2, took just aboutone year to complete IND-enabling studies, from the discovery stage inJanuary 2020. As a small company with a novel mechanism implementedusing out-of-the-box technologies, it took the Company much longertime to actually start clinical trials. Now that it has thisregulatory experience, additional drug developments should not takesuch a long lag time.
“We believethese clinical trials are an important milestone not only forNanoViricides and Karveer Meditech, India, but also for theadvancement of treatments against all viral infections worldwide,”said Dr. Anil Diwan, President and Executive Chairman ofNanoViricides.
NanoViricides’ Treatment OfCoronaviruses
Thecompany’s first drug candidate is NV-CoV-2, a broad-spectrum,anti-coronavirus treatment. Other companies have developed treatmentsfor COVID-19, These include Molnupiravir from Merck & Co. (NYSE: MRK), Paxlovid from Pfizer Inc. (NYSE: PFE) andRemdesivir from Gilead Sciences, Inc. (NASDAQ: GILD). However,there are limitations or drawbacks to each of these treatments.
As a broad-spectrum anti-coronavirus drug,NV-CoV-2 has been shown to work against avariety of unrelated coronaviruses . This suggests thatdifferent strains or mutations are unlikely to escape the drug.Several common coronavirus strains include hCoV-229E, hCoV-OC43,hCoV-HKU1, and hCoV-NL63, which recur seasonally. Of these, NL63 andOC43 present with pneumonia similar to the delta COVID variant insusceptible patients, leading to fatalities at rates that arecomparable to seasonal influenza. Now, SARS-CoV-2 with its variants isadded to this list as a commonly occurring coronavirus.
ANanomedicine Platform For Other Viruses
The trials for NV-CoV-2 are part of thecompany’s development of a novel platform technology employingnanoviricides. The NV-CoV-2 drug contains NV-387, a first-in-classchemical nanomedicine, and its unique mechanism of action (MoA)doesn’t rely on the patient’s immune system to destroy the virus.The Company says that NV-387 mimics an attachment receptor family towhich over 90%of known viruses bind, and NanoViricides hopes that NV-387will likely be a clinically effective drug against at least a few ofthese viruses. The Company has said that it has begun R&D work toexpand the indications of NV-387 to other viruses.
By bringing NV-CoV-2 tohuman trial, NanoViricides has demonstrated the platform’scapability to deliver a clinically relevant antiviral. After the Phase1 studies are completed, the safety and tolerability data will beapplicable to any other viruses that the Company targets usingNV-CoV-2, assuming it can demonstrate pre-clinical success. ThenNV-387 can directly enter Phase 2 as an antiviral against suchadditional viruses — which would likely mean significant cost andtime savings for the additional indications, and substantialimprovement in the return on investment (ROI) for the Company withcommensurate benefits to the investors.
The Company is not a “one-trick pony”either. It already has NV-HHV-1, a drug to treat shingles rashes, that has completed pre-clinical studies. The company believesits platform could provide treatments for a host of viruses, includingother herpesviruses (cold sores, genital ulcers, and many otherserious diseases), as well as influenza and HIV.
This would positionNanoViricides at the intersection of multiple growing treatmentmarkets. The herpes treatment market was worth $1.5billion in 2022 and is predicted to grow at a compound annualgrowth rate (CAGR) of 9.2% over the next seven years. The influenzamarket is expected to reach $1.2billion by 2026 , while the HIV market is predicted to reach $36billion by 2027 .
For now, however, the company is keeping laser-focus on thedevelopment of NV-CoV-2 for treating COVID-19 and long COVID. Itscurrent trial will test the drug’s safety and efficacy, and the datawill be used to prepare for phase 2 trials.
“NV-CoV-2 is aimed atsatisfying the as-yet-unmet medical need of a highly effectivebroad-spectrum, anti-coronavirus drug that can be used for all patientpopulations,” said Diwan. “Moreover, it brings into the clinic anovel platform technology of attacking viruses to develop highlyeffective antiviral drugs.”
Learn more about how NanoViricides 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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NanoViricides,Inc.
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