NanoViricides, Inc.
Pan-coronavirus COVID-19 Drug Candidates Are Highly Effective in
Pre-clinical Animal Studies in Support of FDA Pre-IND
Application
SHELTON, CT / ACCESSWIRE / March 9, 2021 / investorsHub
NewsWire -- NanoViricides, Inc. (NYSE
American: NNVC)
(the "Company"), a leader in the development of highly effective
antiviral therapies based on a novel nanomedicines technology,
reported today on the strong effectiveness of its two COVID-19
clinical drug candidates in an animal model of coronavirus
infection.
The Company is preparing a pre-IND application encompassing its
two clinical drug candidates for the treatment of COVID-19 infected
patients. Of these, NV-CoV-2 is the Company's broad-spectrum
anti-coronavirus drug candidate based on its nanoviricides®
platform that is expected to be capable of attacking most, if not
all, SARS-CoV-2 variants and other coronaviruses. In addition, the
Company is also developing NV-CoV-2-R that combines (1) the power
of NV-CoV-2 to attack and potentially dismantle the virus particles
outside cells, and (2) the power of remdesivir to block further
production of virus particles inside cells. Blocking the complete
lifecycle of the virus in this manner could provide a cure for the
viral disease. The Company intends to perform human clinical
studies to establish the effectiveness of NV-CoV-2 and NV-CoV-2-R
in treating COVID-19 viral infection.
Both NV-CoV-2 and remdesivir are broad-spectrum drugs and are
expected to be effective against most, if not all, variants of the
coronavirus that continue to emerge in the field, based on
pre-clinical studies. The broad-spectrum effectiveness of the
Company's drug candidates is very important as coronavirus variants
that may evade antibodies and cause disease in spite of vaccination
are becoming widespread as the COVID-19 global pandemic is
progressing into its second year. The need for antiviral drugs that
are developed against coronaviruses is now well recognized
(Read in
Buzzfeed News1).
NV-CoV-2 and NV-CoV-2-R were found to be highly effective
against a fully lethal direct-lung coronavirus infection in rats
based on multiple indicators:
Survival: While rats in the untreated infected group
succumbed to the disease in 5 to 6 days, the rats in the NV-CoV-2
treatment group survived for 14 days, and the rats in the
NV-CoV-2-R treatment group survived for 16 days. In contrast, rats
treated with remdesivir formulated in SBECD (comparable to the
FDA-approved Veklury® formulation of remdesivir) survived for only
7.5 days. The total dose of remdesivir was 90mg/kgBW for the
remdesivir treated group, and it was 80mg/kgBW when encapsulated in
the NV-CoV-2-R group. Thus compared to treatment with remdesivir,
treatment with the Company's drug candidate NV-CoV-2 extended the
lifespan by approximately four times more days. Further, treatment
with the Company's other drug candidate NV-CoV-2-R extended the
lifespan by approximately five times more days.
Body Weight: Both NV-CoV-2 and NV-CoV-2-R protected
the animals from body weight (BW) loss that results from the
infection and immune response, in addition to the substantially
increased survival, in this lethal coronavirus infection model.
NV-CoV-2 group lost only about 7% BW (12.5 g/animal) at day 13, and
the NV-CoV-2-R group lost as little as ~1.8% BW (3g/animal) at day
13. In contrast, the remdesivir group had already lost ~17% BW
(30g/animal) by day 7 and succumbed to the disease soon
thereafter.
Additional studies on histopathology of organs and blood
chemistry are in progress.
These results clearly indicate strong effectiveness of NV-CoV-2
as well as NV-CoV-2-R in fighting the coronavirus lung infection
and its ill effects, as compared to the FDA-approved drug
remdesivir.
The (1) significant improvement in lifespan by a factor of four
to five, and (2) the significant prevention of body weight loss,
upon treatment with NV-CoV-2 as well as NV-CoV-2-R as compared to
treatment with the FDA-approved remdesivir are important indicators
for potential human clinical success of the Company's drug
candidates.
The Company studied the effectiveness of these drugs against the
human coronaviruses h-CoV-NL63 (NL63) that uses the same ACE2 human
cellular protein as receptor to gain entry into cells as do all
variants of SARS-CoV-2 and SARS-CoV-1. Additionally, the human
pathology of NL63 infection closely mimics that of SARS-CoV-2,
albeit with limited disease severity. NL63 is a circulating human
coronavirus that can be used in BSL2 labs. NL-63 is therefore being
used as a model for anti-SARS-CoV-2 drug development in various
labs including ours (see Chakraborty and Diwan for a
review2).
Remdesivir (Veklury®, Gilead) has shown relatively weak
effectiveness in animal and clinical studies in contrast to its
strong effectiveness in cell culture studies. This has been related
by scientists to the metabolism of remdesivir in the blood stream
that causes loss of effectiveness. The Company has developed the
drug candidate NV-CoV-2-R by encapsulating ("hiding inside")
remdesivir into NV-CoV-2. The Company believes that this
encapsulation should protect remdesivir from bodily metabolism and
thereby significantly increase its clinical effectiveness.
The strong effectiveness of NV-CoV-2 and NV-CoV-2-R drug
candidates in this animal model is consistent with their previously
reported effectiveness in cell culture studies against infection of
two human coronaviruses, hCoV-NL63, which was used in this animal
efficacy study, and hCoV-229E, another circulating coronavirus that
uses a distinctly different receptor, namely APN. In contrast,
while remdesivir was highly effective in the cell culture studies,
it was not very effective in this animal efficacy study, a result
that is consistent with human clinical studies of remdesivir.
The effectiveness of NV-CoV-2-R observed in this study can be
understood as a combination of (a) the improvement in the
effectiveness of remdesivir due to encapsulation, and (b) the
effectiveness of NV-CoV-2 by itself.
NV-CoV-2-R, the Company believes, is an excellent demonstration
of the power of the nanoviricides platform technology that enables
combining multiple modalities seamlessly into a single drug.
The Company believes that these in vivo study
results support a potential synergistic improvement in the drug
effect as a result of combining the two different mechanisms of
attacking (i) the virus reinfection cycle and (ii) the virus
replication cycle simultaneously.
The Company has developed NV-CoV-2 and NV-CoV-2-R based on its
platform nanoviricides® technology. This approach enables rapid
development of new drugs against a number of different viruses. A
nanoviricide is a "biomimetic" - it is designed to "look like" the
cell surface to the virus. The nanoviricide technology enables
direct attacks at multiple points on a virus particle. It is
believed that such attacks would lead to the virus particle
becoming ineffective at infecting cells. Antibodies in contrast
attack a virus particle at only two attachment points per
antibody.
It is anticipated that when a virus comes in contact with the
nanoviricide, not only would it land on the nanoviricide surface,
binding to the copious number of ligands presented there, but it
would also get entrapped because the nanomicelle polymer would fuse
with the virus lipid envelope, harnessing a well known biophysical
phenomenon called "lipid-lipid mixing". In a sense, a nanoviricide
drug acts against viruses like a "venus-fly-trap" flower does
against insects. Unlike antibodies that tag the virus and require
the human immune system to take over and complete the task of
dismantling the virus, a nanoviricide is a nanomachine that is
designed to not only bind to the virus but also complete the task
of rendering the virus particle ineffective.
In addition, the nanoviricide technology also simultaneously
enables attacking the rapid intracellular reproduction of the virus
by incorporating one or more active pharmaceutical ingredients
(APIs) within the core of the nanoviricide. The
nanoviricide® technology is the only technology in
the world, to the best of our knowledge, that is capable of both
(a) attacking extracellular virus, thereby breaking the reinfection
cycle, and simultaneously (b) disrupting intracellular production
of the virus, thus blocking the complete lifecycle of the virus,
enabling complete control of a virus infection.
The Company has developed NV-CoV-2-R based on this encapsulation
capability that is built into its nanoviricide NV-CoV-2. The
Company has chosen to encapsulate remdesivir as the participating
drug for blocking the viral replication cycle. Remdesivir is
approved by the US FDA for the treatment of patients hospitalized
with COVID-19. Encapsulation of remdesivir in the Company's
nanoviricide envelope is believed to protect it from metabolism in
the body. This protection can be expected to lead to significant
enhancement in the effectiveness of remdesivir itself (in the
encapsulated form), by potentially increasing both the effective
remdesivir concentration and its duration of action. This could be
an additional favorable effect for the Company's anti-coronavirus
drug candidate NV-CoV-2-R. Remdesivir is sponsored by Gilead. The
Company is developing its drug candidates independently at
present.
-
Dan Vergano, "We have vaccines for COVID-19. Why don't we
have good treatments? - 'Everyone was looking for a quick
fix,' Anthony Fauci told BuzzFeed News." Read in BuzzFeed News
(March 6, 2021), https://www.buzzfeednews.com/article/danvergano/coronavirus-treatments-antivirals-fauci
.
-
A. Chakraborty and A. Diwan (2020). "NL63: A Better Surrogate
Virus for studying SARS- CoV-2". Integr Mol
Med, 2020, vol.7, pp 1-9, doi: 10.15761/IMM.1000408.
About
NanoViricides
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
and Ebola/Marburg viruses. The Company has executed a Memorandum of
Understanding with TheraCour that provides a limited license for
research and development for drugs against human coronaviruses. The
Company intends to obtain a full license and has begun the process
for the same. 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.
As is customary, the Company must disclose the risk that the
path to typical drug development of any pharmaceutical product is
extremely lengthy and requires substantial capital. As with any
drug development efforts by any company, there can be no assurance
at this time that any of the Company's pharmaceutical candidates
would show sufficient effectiveness and safety for human clinical
development. Further, there can be no assurance at this time that
successful results against coronavirus in our lab will lead to
successful clinical trials or a successful pharmaceutical
product.
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 NanoViricides, Inc. are "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. You should not
place undue reliance on forward-looking statements since they
involve known and unknown risks, uncertainties and other factors
which are, in some cases, beyond the Company's control and which
could, and likely will, materially affect actual results, levels of
activity, performance or achievements. The Company assumes no
obligation to publicly update or revise these forward-looking
statements for any reason, or to update the reasons actual results
could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Important factors that could cause actual
results to differ materially from the company's expectations
include, but are not limited to, those factors that are disclosed
under the heading "Risk Factors" and elsewhere in documents filed
by the company from time to time with the United States Securities
and Exchange Commission and other regulatory authorities. Although
it is not possible to predict or identify all such factors, they
may include the following: demonstration and proof of principle in
preclinical trials that a nanoviricide is safe and effective;
successful development of our product candidates; our ability to
seek and obtain regulatory approvals, including with respect to the
indications we are seeking; the successful commercialization of our
product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. IND application
refers to "Investigational New Drug" application. cGMP refers to
current Good Manufacturing Practices. CMC refers to "Chemistry,
Manufacture, and Controls". CHMP refers to the Committee for
Medicinal Products for Human Use, which is the European Medicines
Agency's (EMA) committee responsible for human medicines.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
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