By David Willey, Benzinga
NanoViricides (NYSE American: NNVC) has begun trials for its new drug candidate, NV-CoV-2 an exciting development for the biotech company, as it starts its first human trials with drug sponsor Karveer Meditech Pvt. Ltd. India, the companys licensee and co-developer in India.
NanoViricides has been building out a novel nanomedicine platform for many years, and this platform now includes a pipeline of multiple preclinical antiviral drugs. The Company is developing antiviral medications that are built on the companys patented nanoviricide technology. Nanomedicine has a lot of promise, but there are almost no nanomedicines available on the market to treat viral infections. Because of prior acquired expertise, NanoViricides first-in-class COVID drug, NV-CoV-2, took just about one year to complete IND-enabling studies, from the discovery stage in January 2020. As a small company with a novel mechanism implemented using out-of-the-box technologies, it took the Company much longer time to actually start clinical trials. Now that it has this regulatory experience, additional drug developments should not take such a long lag time.
We believe these clinical trials are an important milestone not only for NanoViricides and Karveer Meditech, India, but also for the advancement of treatments against all viral infections worldwide, said Dr. Anil Diwan, President and Executive Chairman of NanoViricides.
NanoViricides Treatment Of Coronaviruses
The companys first drug candidate is NV-CoV-2, a broad-spectrum, anti-coronavirus treatment. Other companies have developed treatments for COVID-19, These include Molnupiravir from Merck & Co. (NYSE: MRK), Paxlovid from Pfizer Inc. (NYSE: PFE) and Remdesivir 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 a variety of unrelated coronaviruses. This suggests that different 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 and OC43 present with pneumonia similar to the delta COVID variant in susceptible patients, leading to fatalities at rates that are comparable to seasonal influenza. Now, SARS-CoV-2 with its variants is added to this list as a commonly occurring coronavirus.
A Nanomedicine Platform For Other Viruses
The trials for NV-CoV-2 are part of the companys development of a novel platform technology employing nanoviricides. The NV-CoV-2 drug contains NV-387, a first-in-class chemical nanomedicine, and its unique mechanism of action (MoA) doesnt rely on the patients immune system to destroy the virus. The Company says that NV-387 mimics an attachment receptor family to which over 90% of known viruses bind, and NanoViricides hopes that NV-387 will likely be a clinically effective drug against at least a few of these viruses. The Company has said that it has begun R&D work to expand the indications of NV-387 to other viruses.
By bringing NV-CoV-2 to human trial, NanoViricides has demonstrated the platforms capability to deliver a clinically relevant antiviral. After the Phase 1 studies are completed, the safety and tolerability data will be applicable to any other viruses that the Company targets using NV-CoV-2, assuming it can demonstrate pre-clinical success. Then NV-387 can directly enter Phase 2 as an antiviral against such additional viruses which would likely mean significant cost and time savings for the additional indications, and substantial improvement in the return on investment (ROI) for the Company with commensurate 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 believes its platform could provide treatments for a host of viruses, including other herpesviruses (cold sores, genital ulcers, and many other serious diseases), as well as influenza and HIV.
This would position NanoViricides at the intersection of multiple growing treatment markets. The herpes treatment market was worth $1.5 billion in 2022 and is predicted to grow at a compound annual growth rate (CAGR) of 9.2% over the next seven years. The influenza market is expected to reach $1.2 billion by 2026, while the HIV market is predicted to reach $36 billion by 2027.
For now, however, the company is keeping laser-focus on the development of NV-CoV-2 for treating COVID-19 and long COVID. Its current trial will test the drugs safety and efficacy, and the data will be used to prepare for phase 2 trials.
NV-CoV-2 is aimed at satisfying the as-yet-unmet medical need of a highly effective broad-spectrum, anti-coronavirus drug that can be used for all patient populations, said Diwan. Moreover, it brings into the clinic a novel platform technology of attacking viruses to develop highly effective antiviral drugs.
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-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it. 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 intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.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 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.
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