Safety and Tolerability of
Anti-Coronavirus Drug Candidates Observed in an Animal Model
Further Advances NanoViricides’ SARS-CoV-2 Therapeutics
Program
Shelton, CT -- July 8,
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 excellent safety
and tolerability of the drug candidates it is developing against
SARS-CoV-2 to treat COVID-19 spectrum of diseases was observed in
an animal model. The nanoviricides drug candidates tested in this
safety/tolerability study have previously shown strong
effectiveness against lung infection by a SARS-CoV-2 like
coronavirus, namely, hCoV-NL63, in an animal study as previously
reported by the Company.
Three different
drug candidates at three different dosage levels (low, medium, and
high) and vehicle control were administered to separate groups of
mice intravenously in the Safety-Tolerability study reported here.
Clinical observations and gross post-mortem studies have been
completed. The tested drug candidates were safe and well tolerated,
thereby clearing the path for further development towards a
treatment for SARS-CoV-2 infection that has caused the current
COVID-19 pandemic.
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.
Additionally, it is well known that
viruses escape antibody-drugs via mutations. The Company’s
“nanoviricide” drug candidates, in contrast, are designed to be
broad-spectrum, and therefore virus escape by mutations is expected
to be unlikely.
In this
Safety/Tolerability Study, there were no clinical signs of immune
or allergic reactions such as itching, biting, twitching, rough
coat, etc. Further, there were no observable changes in any organs
including large intestine or colon on post mortem in gross histology. The only reportable changes
observed were, in the high dosage groups of two of the three drug
candidates tested, associated with the non-absorption of water, in
the colon. This is consistent with the clinical observation of very
loosened stools in the same groups. In clinical
usage, the drug candidates are not anticipated to be administered
in such high levels. The objective of this study was to discover
the dosage level at which such an effect may
occur.
Sixteen mice in each group (8 males, 8
females), were administered one of the three drug candidates at one
of the three dose levels, and additionally, one group was
administered vehicle control, for seven days by daily tail-vein intravenous infusion in
this blinded study with additional evaluations on 8th day. This
non-GLP safety/tolerability study was conducted under GLP-like
conditions by AR BioSystems, Inc., Odessa, Tampa, FL.
Further microscopic histology and
blood work analyses are in progress.
The Company
believes that loose or very loose stools at very high dosages in
such a study is an expected and acceptable side effect of the
polyethylene glycol (PEG) moiety, which forms the backbone of the
nanoviricides drug candidates. PEG is used prior to colonoscopy in
humans to promote loose stools and internal cleaning of the
intestines, by causing non-absorption of water.
The Company has previously reported
that these drug candidates have shown strong effectiveness in a
lethal lung infection model in rats using a coronavirus that uses
the same ACE2 receptor as SARS-CoV-2 which causes COVID-19, namely
hCoV-NL63. The Company has found that hCoV-NL63,
which causes a milder disease than SARS-CoV-2, causes substantially
similar clinical pathology in this efficacy animal model as has
been reported for SARS-CoV-2 associated lung infections in
humans.
In this previously reported lethal
direct-lung-infection model efficacy study, 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.
In this efficacy
study, animals treated with the five different nanoviricides showed
significantly reduced body weight loss. The body weight loss in
female animals ranged from only 3.9% to 11.2% in the different
nanoviricide-treated groups, as compared to 20% in vehicle-treated
control group, and 15.2% in a remdesivir-treated
group (n=5 in each
group). The body weight loss in male animals ranged from 8.0% to
10.9% in the different nanoviricides-treated groups, as compared to
25% in the vehicle-treated control group, and 18.6% in
remdesivir-treated group (n=5 in each group). 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 the lung-infection
model is consistent with the effectiveness observed in cell culture
studies against infection of both hCoV-NL63, which was used in the
efficacy study, and hCoV-229E, another circulating coronavirus that
uses a distinctly different receptor, namely APN.
Prior to filing for human clinical
trials, NanoViricides plans on conducting studies, towards clinical
candidate selection, to further determine the effectiveness against
SARS-CoV-2, perform additional drug development studies as may be
necessary, and request a pre-IND Meeting with the US FDA for
regulatory guidance.
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 in the process of
completing an IND application to the US FDA for this drug
candidate. The Company cannot project an exact date for filing an
IND because of its dependence on a number of external collaborators
and consultants, and the effects of recent COVID-19
restrictions.
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.
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. CMC refers to
“Chemistry, Manufacture, and Controls”.
Contact:
NanoViricides,
Inc.
info@nanoviricides.com
Public Relations
Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
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