SHELTON, CT / ACCESSWIRE, May 20, 2020 - (ACN Newswire) -
NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a leader
in the development of highly effective antiviral therapies based on
a novel nanomedicines platform, announced today that strong
effectiveness against infection by an ACE2-utilizing coronavirus in
an animal model has been observed for the drug candidates it is
developing against SARS-CoV-2 to treat COVID-19 spectrum of
diseases.
NanoViricides is developing an animal model for coronavirus
infection using hCoV-NL63 as a surrogate for SARS-CoV-2, the virus
that causes COVID-19 disease. HCoV-NL63 is a circulating human
coronavirus that causes a disease that is similar to SARS-CoV-2,
but much milder. Both viruses utilize the same cell receptor,
namely ACE2, to gain entry into the cell. Because it causes a mild
disease, hCoV-NL63 can be used in BSL2 environments, and the
Company believes it is a useful surrogate for development of
therapeutics against SARS-CoV-2 infection.
In this lethal direct-lung-infection model, animals in all groups
developed lung disease which later led to multi-organ failures, a
clinical pathology resembling that of the SARS-CoV-2. Reduction in
loss of body weight at day 7 was used as the primary indicator of
drug effectiveness. Rats were infected directly into lungs with
lethal amounts of hCoV-NL63 virus particles and then different
groups were treated separately with five different nanoviricides
drug candidates, remdesivir as a positive control, and the vehicle
as a negative control. The treatment was intravenous by tail-vein
injection once daily for five days, except in the case of
remdesivir wherein it was by tail-vein injection twice daily.
Animals treated with the five different nanoviricides showed
significantly reduced body weight loss. The body weight loss was
only 3.9% for the best nanoviricide candidate, ranging to 11.2% for
the potentially least effective one, as compared to 20% in the
vehicle-treated control group, in female animals (n=5 in each
group). Male animals treated with the same nanoviricides also
showed significantly reduced body weight loss. The body weight loss
in male animals was 8.0% for the best nanoviricide candidate and
ranged up to 10.9% for the potentially least effective one, as
compared to 25% in the vehicle-treated control group (n=5 in each
group). In comparison, remdesivir treatment led to a body weight
loss of 15.2% in females and 18.6% in males in this study (see
below). Smaller numbers mean less loss in body weight compared to
starting body weight in the group, and indicate greater drug
effectiveness.
The strong effectiveness of nanoviricide drug candidates in this
model is consistent with the effectiveness observed in cell culture
studies against infection of both hCoV-NL63, which was used in this
study, and hCoV-229E, another circulating coronavirus that uses a
distinctly different receptor, namely APN.
Thus this study corroborates the previous cell-culture
effectiveness reported by the Company and provides confidence to
the Company that these nanoviricides drug candidates may be
expected to result in a clinical candidate to be pursued in human
clinical trials.
The Company believes the fact that these nanoviricides
anti-coronavirus drug candidates are highly effective against two
distinctly different coronaviruses that use different cellular
receptors is very significant. Specifically, it provides a rational
basis to scientists indicating that even if the SARS-CoV-2
coronavirus mutates, the nanoviricides can be expected to continue
to remain effective.
Importantly, nanoviricides are designed to act by a novel mechanism
of action, trapping the virus particle like the "Venus-fly-trap"
flower does for insects. Antibodies, in contrast, only label the
virus for other components of the immune system to take care of. It
is well known that the immune system is not functioning properly at
least in severe COVID-19 patients.
The Company believes that these nanoviricides drug candidates are
potentially superior to favipravir, based on cell culture studies
and may be superior to remdesivir based on the results of this
study, however, a definite conclusion to that effect cannot be
drawn. Oral favipravir and infusion of remdesivir are two
anti-viral drugs in clinical trials for the treatment of
COVID-19.
Prior to filing for human clinical trials, NanoViricides plans on
conducting studies to further determine the effectiveness against
SARS-CoV-2, perform drug development studies for safety/toxicology,
and request a pre-IND Meeting with the US FDA for regulatory
guidance.
Human coronavirus NL63 (hCoV-NL63) uses the same ACE2 receptor as
the SARS-CoV-2 that causes CoVID-19. Both in terms of its clinical
pathology, and its receptor usage, it is known to be very similar
to SARS-CoV-2, except much milder. Therefore the Company believes
hCoV-NL63 is a good surrogate model for therapeutics development
against SARS-CoV-2. HCoV-NL63 can be studied in a BSL2 lab whereas
SARS-CoV-2 currently requires a BSL3 or BSL4 facility.
The striking difference in weight loss between the two sexes in
this animal model was remarkable. It has been widely reported that
men are more likely to suffer severe infection and fatalities from
SARS-CoV-2 than women in the current pandemic. This feature was
replicated in our animal model study indicating that biological sex
differences are the driver of the differences in the severity of
infection by the coronaviruses that utilize the ACE2 receptor.
The various receptors used by different coronaviruses appear to
fall in the broad family of membrane-associated serine proteases.
As a family, they share several structural features. Their
substrate specificities are dictated by specific amino acid
residues and their positions. However, the coronaviruses do not
appear to insert into the specific substrate sites on their
receptors as can be broadly deduced from limited, available
knowledge of these interactions. NanoViricides believes that this
has made it possible for the Company to develop receptor-mimetic
virus-binding ligands that have broad-spectrum effectiveness
against multiple coronaviruses that use different receptors.
HCoV-NL63 is known to cause severe lower respiratory tract
infections in young children leading to hospitalization. The
symptoms are generally less severe than SARS-CoV-2 but are similar.
In most cases, hCoV-NL63 causes relatively mild disease, often
associated with croup, bronchiolitis, and lower respiratory tract
disease in children, and is considered to cause some of the common
colds in adults. Thus, the clinical manifestation of hCoV-NL63
infection in pediatric patients is similar to that of SARS-CoV-2,
although much less severe. SARS-CoV-2 causes clinically similar
milder forms of disease in most patients, but moderate to severe
disease requiring hospitalizations in about 15-20% of infected
persons. These similarities imply that hCoV-NL63 should be a
reasonable model virus for antiviral cell culture and animal
studies in BSL2 environment in the course of antiviral drug
development for SARS-CoV-2.
About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development stage
company that is creating special purpose nanomaterials for
antiviral therapy. The Company's novel nanoviricide(R) 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. 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.
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 does not currently have a
license to the coronavirus field, however, TheraCour has not denied
any licenses to the Company. The Company typically begins the
licensing process only after demonstrating effectiveness of some
candidates in optimization stage.
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.
As with any drug development efforts, there can be no assurance
that any of these candidates would show sufficient effectiveness
and safety for human clinical development at this time.
There can be no assurance that the Company will be successful in
establishing the necessary collaborations, although the Company has
been successful at establishing necessary collaborations for its
drug programs in the past.
FDA refers to US Food and Drug Administration. IND application
refers to "Investigational New Drug" application. CMC refers to
"Chemistry, Manufacture, and Controls".
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
Source: NanoViricides, Inc.
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