Strong
Effectiveness of NanoViricides Drug Candidates Observed in an
Animal Model of Infection by an ACE2-using Human
Coronavirus
Shelton, Connecticut -- May
20, 2020 --
InvestorsHub 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® 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
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Aug 2024 to Sep 2024
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Sep 2023 to Sep 2024