Shelton -
NV-CoV-2 drugs contain the active pharmaceutical ingredient NV-387. NV-387 is an ultra-broad-spectrum antiviral nanomedicine that is designed by copying a common host-side chemical signature used by viruses to effectively infect and cause disease in the human and animal hosts.
'We believe that the strong demonstration of safety and tolerability in the clinical trial sets NV-387 on a path of long-term success against many viruses,' said Dr.
No matter how much the virus changes, it continues to use the same host-side signature to bind to and cause infection in the hosts, and thus the nanoviricide would be anticipated to continue to be effective.
The nanoviricide technology involves copying the invariant and essential host-side signature and, using this signature, building a direct-acting antiviral that destroys the virus. This design feature of nanoviricides solves the most intractable issue in antiviral response, that of viruses escaping the vaccines, antibodies, and small chemical drugs.
Ultra-Broad-Spectrum Antiviral Nanomedicines Enabled by the Nanoviricides Platform Would Open Up Very Large Market Sizes
In addition, NV-387 is designed using the host-side signature that over 90% of human pathogenic viruses use for creating a successful infection in the human or animal hosts. This means NV-387 is likely to be active against a large number of viruses and could be sufficiently active against many of them to become a successful clinical drug against them.
In fact, we have already demonstrated that NV-387 is highly effective in preclinical studies against lethal RSV infection as well as against lethal Smallpox-like virus infections.
There is no drug for general treatment of RSV infection at present, enabling NV-387 to be a candidate for this
There is a strong interest in developing additional antivirals against Smallpox, because of the potential bioterrorism threat. It is known that Smallpox virus can escape the approved drug tecovirimat by a single point mutation.
COVID is here to stay, and even as the pandemic has largely subsided, the need for COVID therapeutics is in the range of tens of billions of dollars. Long COVID also remains a problem that effective antiviral such as NV-387 could make a difference in.
NV-387 is designed to mimic the host-side signature called 'Sulfated Proteoglycans' ('S-PG'). This signature is used by over 90% of human pathogenic viruses, a very long list indeed. Success against a few of these viruses could build NV-387 into a drug that targets over
The Strong Safety of NV-387 Is Expected to Enable Its Use Across All Patients.
The strong safety and tolerability of NV-387 demonstrated in human clinical trial implies that it can be used: (i) across all ages from pediatrics to seniors; (ii) irrespective of co-morbidities such as diabetes, other pre-existing diseases, or immune compromised status of the individual and (iii) at all levels of disease severity, from mild/moderate to severe to very severe (hospitalized patients).
This capability of NV-387 is analogous to the highly successful antibiotics against bacteria.
In contrast, currently available antiviral drugs have strong limitations on the patient populations that they can be used in. For example, of the two remaining approved drugs for treatment of COVID, Paxlovid which is given orally, is not indicated for the treatment of COVID-19 in patients without a risk factor for progression to severe COVID-19, whereas Remdesivir can only be used in hospitalized cases.
Antibiotics caused a major revolution in how we treat bacterial infections, with the discovery of the broad-spectrum antibacterial, penicillin. Penicillin attacks the chemical signature common to whole classes of bacteria. Thereby it attacks the bacterial surface and causes dismantling of the bacteria.
The success of penicillin led to an explosion in development of antibacterials that use the same mechanism of action and provide additional benefits, stronger activity against certain bacteria and oral administration amongst them.
In fact, the world continues to use amoxicillin to treat most pediatric and adult bacterial infections to this day, some 65 years since its discovery in 1958! This durability is a direct result of the fact that most of the bacteria it attacks have not escaped the drug and have remained susceptible even after such a long time of common use.
We note that we have been able to develop NV-387 already for oral administration, as well as for injectable and inhalation formulations to enable many modes of use.
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Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.
The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.
The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases.
Disclosure Statement
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by
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