LOS GATOS, Calif., Dec. 21, 2021 /PRNewswire/ -- Aridis
Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company
focused on the discovery and development of novel anti-infective
therapies to treat life-threatening infections, announced today
that its fully human monoclonal antibody (mAb) cocktail AR-701 is
broadly reactive against the Omicron and other COVID-19
(SARS-CoV-2) variants, SARS (Severe Acute Respiratory Syndrome),
MERS (Middle East Respiratory Syndrome Coronavirus), and seasonal
('common cold') human coronaviruses.
- AR-703, one of the components of the AR-701 cocktail, binds to
the 'S2' stalk region of coronavirus spike proteins that is
responsible for viral fusion and entry into host cells, and binds
to the Omicron variant with no loss in affinity as compared to the
original Wuhan strain.
- In vitro neutralization studies using live coronaviruses showed
that AR-701 achieved broad, potent neutralization against all
SARS-CoV-2 variants tested, as well as SARS, MERS, and the seasonal
'common cold' betacoronaviruses.
- In vivo data with multiple animal challenge models that are
widely used to evaluate COVID-19 treatments support AR-701's broad
efficacy.
- AR-701 is engineered to be long-acting, and is expected to
provide relevant drug levels for up to 1 year from prophylactic or
therapeutic treatment.
"Omicron has rendered current COVID-19 vaccines and monoclonal
antibodies substantially less effective, and likely future COVID 19
variants will arise that continue this trend" said Vu Truong, Ph.D., Chief Executive Officer of
Aridis Pharmaceuticals. "AR-701 is the result of our successful
search for a mAb therapy that is directed against a conserved
region of the virus that would be less vulnerable to mutations and
new variants such as Omicron. Our laboratory data suggest that
AR-701 has the potential to be a future-proof COVID-19 therapy that
can protect against SARS-CoV-2, SARS, or MERS pandemics," continued
Dr. Truong. "To our knowledge AR-701 is the only COVID-19 therapy
that targets two distinct viral mechanisms of action, making it
much harder for the virus to generate resistance, and exhibits
an unmatched combination of broad reactivity and high efficacy,"
continued Dr. Truong.
About AR-701
AR-701 is a cocktail of two fully human
immunoglobulin G1 (IgG1) mAbs discovered from screening the
antibody secreting B-cells of convalescent SARS-CoV-2 infected
(COVID-19) patients. AR-701 consists of AR-703 and AR-720 mAbs,
each neutralizes coronaviruses using distinct mechanisms of action,
namely inhibition of viral fusion and entry into human cells
(AR-703) and blockage of viral binding to the human 'ACE2' receptor
(AR-720). The two mAbs complement and enhance each other in a
synergistic fashion, creating a potent first-in-class cocktail.
AR-703 binds to the 'S2' stalk region of spike proteins from
betacoronaviruses, including the SARS-CoV2 variants (beta, gamma,
delta, epsilon), and binds to the Omicron variant with no loss in
affinity compared to the original Wuhan strain. Multiple animal challenge models
widely used to evaluate COVID-19 treatments support AR-701's broad
efficacy, including:
- AR-701 mAbs administered parenterally, either individually or
in combination with one another, eradicated SARS-CoV-2
(Wuhan strain) from the lungs of
infected mice.
- Hamsters infected with the SARS-CoV-2 (Delta variant) and later
treated once with inhaled AR-701 mAbs, either individually or in
combination, were protected from disease and weight loss.
- Mice infected with the Severe Acute Respiratory Syndrome virus
(SARS) were also protected from disease and weight loss with a
single inhaled dose of AR-701.
The AR-701 mAbs are engineered to be active for 6-12 months in
the blood. AR-701 is being developed as a long-acting intramuscular
as well as a self-administered inhaled formulation for the
treatment of COVID-19 patients who are not yet hospitalized. AR-701
mAbs were discovered through a collaboration with researchers at
the University of Alabama in Birmingham
and Texas Biomedical Research Institute (San Antonio, TX).
About Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals, Inc. discovers and develops novel
anti-infective therapies to treat life-threatening
infections, including anti-infectives to be used as add-on
treatments to standard-of-care antibiotics. The Company is
utilizing its
proprietary ʎPEXTM and MabIgX® technology
platforms to rapidly identify rare, potent antibody-producing
B-cells from patients who have successfully overcome an infection,
and to rapidly manufacture monoclonal antibody (mAbs) for
therapeutic treatment of critical infections. These mAbs are
already of human origin and functionally optimized for high potency
by the donor's immune system; hence, they technically do not
require genetic engineering or further optimization to achieve full
functionality.
The Company is advancing multiple clinical stage mAbs targeting
bacteria that cause life-threatening infections such as ventilator
associated pneumonia (VAP) and hospital acquired
pneumonia (HAP), in addition to preclinical stage antiviral
mAbs. The use of mAbs as anti-infective treatments represents an
innovative therapeutic approach that harnesses the human immune
system to fight infections and is designed to overcome the
deficiencies associated with the current standard of care which is
broad spectrum antibiotics. Such deficiencies include, but are not
limited to, increasing drug resistance, short duration of efficacy,
disruption of the normal flora of the human microbiome and lack of
differentiation among current treatments. The mAb portfolio is
complemented by a non-antibiotic novel mechanism small molecule
anti-infective candidate being developed to treat lung infections
in cystic fibrosis patients. The Company's pipeline is highlighted
below:
Aridis' Pipeline
AR-301 (VAP). AR-301 is a fully human IgG1 mAb
targeting gram-positive Staphylococcus
aureus (S. aureus) alpha-toxin and is being
evaluated in a global Phase 3 clinical study as an adjunctive
treatment of S. aureus ventilator associated pneumonia
(VAP).
AR-320 (VAP). AR-320 is a fully human IgG1 mAb
targeting S. aureus alpha-toxin that is being developed
as a preventative treatment of S. aureus colonized
mechanically ventilated patients who do not yet have VAP. Phase 3
is expected to be initiated in 2Q22.
AR-501 (cystic fibrosis). AR-501 is an inhaled
formulation of gallium citrate with broad-spectrum anti-infective
activity being developed to treat chronic lung infections in cystic
fibrosis patients. This program is currently in Phase 2a
clinical development in CF patients.
AR-701 (COVID-19). AR-701 is a cocktail of fully
human mAbs discovered from convalescent COVID-19 patients that are
directed at multiple protein epitopes on the SARS-CoV-2 virus. It
is formulated for delivery via intramuscular injection or
inhalation using a nebulizer. AR-701 replaces AR-712 as the
company's leading COVID mAb candidate.
AR-401 (blood stream infections). AR-401 is a
fully human mAb preclinical program aimed at treating infections
caused by gram-negative Acinetobacter baumannii.
AR-101 (HAP). AR-101 is a fully human
immunoglobulin M, or IgM, mAb in Phase 2 clinical development
targeting Pseudomonas aeruginosa (P.
aeruginosa) liposaccharides serotype O11, which accounts
for approximately 22% of all P.
aeruginosa hospital acquired pneumonia cases
worldwide.
AR-201 (RSV infection). AR-201 is a fully human IgG1
mAb out-licensed preclinical program aimed at neutralizing diverse
clinical isolates of respiratory syncytial virus (RSV).
For additional information on Aridis Pharmaceuticals, please
visit https://aridispharma.com/.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties.
These statements may be identified by the use of words such as
"anticipate," "believe," "forecast," "estimated" and "intend" or
other similar terms or expressions that concern Aridis'
expectations, strategy, plans or intentions. These forward-looking
statements are based on Aridis' current expectations and actual
results could differ materially. There are a number of
factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. These
factors include, but are not limited to, the need for additional
financing, the timing of regulatory submissions, Aridis' ability to
obtain and maintain regulatory approval of its existing product
candidates and any other product candidates it may develop,
approvals for clinical trials may be delayed or withheld by
regulatory agencies, risks relating to the timing and costs of
clinical trials, risks associated with obtaining funding from third
parties, management and employee operations and execution risks,
loss of key personnel, competition, risks related to market
acceptance of products, intellectual property risks, risks related
to business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm our financial
condition and increase our costs and expenses, risks
associated with the uncertainty of future financial results,
Aridis' ability to attract collaborators and partners and risks
associated with Aridis' reliance on third party
organizations. While the list of factors presented here is
considered representative, no such list should be considered to be
a complete statement of all potential risks and uncertainties.
Unlisted factors may present significant additional obstacles to
the realization of forward-looking statements. Actual results could
differ materially from those described or implied by such
forward-looking statements as a result of various important
factors, including, without limitation, market conditions and the
factors described under the caption "Risk Factors" in Aridis' 10-K
for the year ended December 31, 2020
and Aridis' other filings made with the Securities and Exchange
Commission. Forward-looking statements included herein are
made as of the date hereof, and Aridis does not undertake any
obligation to update publicly such statements to reflect subsequent
events or circumstances.
Contact:
Media Communications:
Matt Sheldon
RedChip Companies Inc.
Matt@redchip.com
1.917.280.7329
Investor Relations
Dave Gentry
RedChip
Dave@redchip.com
1-800-733-2447
View original content to download
multimedia:https://www.prnewswire.com/news-releases/aridis-pharmaceuticals-announces-a-pan-coronavirus-monoclonal-antibody-cocktail-that-retains-effectiveness-against-the-omicron-variant-other-covid-19-variants-sars-mers-and-the-common-cold-human-coronaviruses-301448791.html
SOURCE Aridis Pharmaceuticals, Inc.