NanoViricides Develops Highly
Effective
Broad-Spectrum
Drug
Candidates Against Coronaviruses
Shelton, CT -- May
12, 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 it has developed drug candidates that
have demonstrated
very
high anti-viral
effectiveness in
cell culture studies against
multiple coronaviruses.
Two of
the tested nanoviricides drug candidates were highly effective in
cell culture assays against multiple coronaviruses that infect
humans. In particular, they were several-fold more effective
than favipravir
(aka
T-705), against the tested viruses. Favirpravir
is a
broad-spectrum nucleoside-like analog drug that is in clinical
testing against SARS-CoV-2, originally developed by
Fujifilm.
The
Company has tested its drug candidates for anti-viral
effectiveness
against two distinctly different, unrelated coronaviruses that
cause human disease, namely hCoV-NL63, and hCoV-229E.
The
assays evaluated the reduction caused by the drug candidate in cell
death upon viral infection, formally known as cytopathic
effects (CPE)
assays.
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.
H-CoV-Nl63
can be studied in a BSL2 lab whereas SARS-CoV-2 currently requires
a BSL3 or BSL4 facility.
The
Company also found that the same two nanoviricides drug candidates
were highly effective
against another coronavirus, namely
hCoV-229E,
that causes seasonal
common colds in humans. These nanoviricides
drug candidates were several-fold
more effective than favipravir
in this
human common colds
coronavirus
as
well.
HCoV-229E
uses the APN (Aminopeptidase-N) membrane protein on human
cells as its receptor to enter cells, different from
hCoV-NL63 and SARS-CoV-2.
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, the Company
believes. Specifically, it
provides confidence to the Company and rational basis
to scientists 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.
In
addition, it is generally thought that SARS-CoV-2 may be able to
escape antibodies being developed as drugs. Antibodies
are
known to become ineffective upon
viral mutations.
Moreover, there is
a significant scientific debate
about whether vaccines may be able to produce protective immunity
against SARS-CoV-2.
Thus,
the Company believes that the nanoviricides drug candidates it has
developed are potentially superior to favipravir
and are
expected to warrant human clinical studies. 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 studies, NanoViricides
plans
on conducting studies to further determine the effectiveness
against SARS-CoV-2, and perform
certain
animal studies for safety/toxicology.
The
Company believes that
broad-spectrum
anti-coronavirus drugs such as its nanoviricides drug candidates
are expected to provide the ideal solution for combatting COVID-19,
provided that the candidates show effectiveness in human clinical
trials.
The
various receptors used by
different coronaviruses all 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 the course of
antiviral drug development for SARS-CoV-2. 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
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