LOS GATOS, Calif., Feb. 23, 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 it has augmented its inhaled AR-711 monoclonal antibody (mAb)
to COVID-19 with a second mAb (AR-713) that is designed to
neutralize newly emerging COVID-19 mutated variants including those
from South Africa, Brazil and Japan. Together, the enhanced dual antibody
cocktail will be delivered as an inhaled treatment and is expected
to provide broad coverage of all known high-risk strains. In
addition, Aridis is pleased to announce preclinical development
services support from NIAID. The preclinical development services
support is also provided by the Coronavirus Immunotherapy
Consortium (CoVIC). Aridis is on track to initiate the program's
Phase 1/2/3 clinical trial in 2H 2021.
AR-711 is being developed as a self-administered, at-home
inhaled treatment for COVID-19 patients who are not yet
hospitalized. The Company's vision is that if highly effective
immunotherapies such as mAbs could be formulated as inhaled
therapy, then COVID-19 patients could be treated much earlier in
the course of their disease within their own homes. This could
offer convenience to patients and reduce pressure on medical
infrastructure, including outpatient infusion centers and
hospitals. As the pandemic evolves, new mutant and more contagious
strains of the SARS-CoV-2 virus have emerged, rendering most
available vaccines and monoclonal antibodies less effective. In
response, the Company is now adding a second mAb AR-713, which has
been shown to completely neutralize in vitro the 'E484K'
mutation containing SARS-CoV-2 variant, associated with the
Brazilian and Japanese variants (P.1) and the South African variant
(B.1.351). This enhanced cocktail is designed to neutralize these
variants as well as the original strain, the D614G strain, and the
UK strain (B.1.1.7), providing broad coverage of all currently
known high-risk strains.
"As the COVID-19 pandemic spreads globally, the virus continues
to mutate into variants which render the majority of the available
vaccines and mAbs less effective," commented Vu Truong, Ph.D., Chief Executive Officer of
Aridis Pharmaceuticals. "Scientists at Aridis continue to
collaborate with multiple global research organizations in their
ongoing search for the best agents to target this rapidly-changing
virus. We are committed to being nimble and adjust our treatment,
as needed, in order to keep pace with the virus as it continues to
evolve. The addition of AR-713 follows this strategy of rapid
responsiveness."
"Even at peak COVID-19 vaccination coverage, it is expected that
up to a third of the world's population will remain unvaccinated
and at risk of contracting COVID-19, thus requiring treatment
intervention. This is exactly where treatment modalities such as
our inhaled COVID-19 mAb cocktail could fill the gap, i.e. by
neutralizing the circulating and variant viral strains allowing
infected individuals to be treated earlier and recover at home,"
continued Truong. "We are pleased to deliver a second mAb to
provide broad coverage including the newly emerging COVID-19
strains. We are also thankful to our collaborators at NIAID/CoVIC
whose lab work is helping us complete our FDA and EMA dossiers for
an expeditious start of the Phase 1/2/3 clinical trials."
The Company remains on track to finalize the Phase 1/2/3 design
for this program and obtain concurrence from the FDA and EMA in 1H
2021 such that patient enrollment can be initiated in 2H 2021.
About AR-711 and AR-713
AR-711 and AR-713 are fully
human immunoglobulin G1 (IgG1) mAbs discovered from screening the
antibody secreting B-cells of convalescent SARS-CoV-2 virus
infected (COVID-19) patients. These mAbs target the SARS-CoV-2
virus' receptor-binding domain (RBD) region of the spike protein at
a distinct, unique site. They are also engineered to be active
for 6-12 months in the blood and formulated for effective delivery
from commercially available nebulizers. Due to its direct delivery
to the lungs by inhaled administration, AR-711 and AR-713 may
facilitate more rapid, broader treatment coverage, and at a
substantially lower dose as compared to parenteral administration.
AR-711 exhibits high affinity for SARS-CoV-2 spike protein,
approximately 10-fold higher than other mAb candidates currently in
late stage clinical testing, and neutralizes the original
SARS-CoV-2 strain, the D614G strain, and the UK strain (B.1.1.7).
AR-711 was previously shown to be effective in prophylactic as well
as therapeutic treatment modes in a SARS-CoV-2 viral challenge
pre-clinical study. AR-713 extends the binding and neutralization
of SARS-CoV-2 strains to include the 'E484K' mutation related
strains, which include the Brazilian and Japanese variants (P.1)
and the South African variant (B.1.351). Both AR-711 and AR-713
were originally discovered through a collaboration with the
University of Alabama (Birmingham) and
the Texas Biomedical Research Institute. Collectively, the cocktail
of AR-711 and AR-713 are referred to as AR-712.
About NIAID and CoVIC Consortium
NIAID (National
Institute of Allergy and Infectious Diseases) is one of the 27
institutes and centers that make up the National Institutes of
Health (NIH), an agency of the United States Department
of Health and Human Services. CoVIC is a global partnership created
to accelerate discovery, optimization, and delivery of
antibody-based therapeutics against SARS-CoV-2. It is an
academic-industry and non-profit research collaboration that brings
together scientists from around the world to study and assess which
antibodies are most effective against the coronavirus SARS-CoV-2,
and to streamline and accelerate the research pipeline for
antibody-based therapeutics needed against SARS-CoV-2. The funders
of CoVIC include the Bill & Melinda Gates Foundation, the
Wellcome Trust, NIAID, and MasterCard. The company's receiving of
the preclinical services support from NIAID and CoVIC should not be
construed as endorsements of the company's products.
About Aridis Pharmaceuticals, Inc.
Aridis
Pharmaceuticals, Inc. discovers and develops 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 has generated 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 currently in Phase 3 clinical development
targeting gram-positive Staphylococcus
aureus (S. aureus) alpha-toxin in
VAP patients.
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-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-401 (blood stream infections). AR-401 is a
fully human mAb preclinical program aimed at treating infections
caused by gram-negative Acinetobacter baumannii.
AR-701 (COVID-19). AR-701 is a cocktail of fully
human mAbs discovered from convalescent COVID-19 patients that are
directed at multiple envelope proteins of the SARS-CoV-2 virus.
AR-712 (COVID-19). AR-712 is a cocktail of fully
human mAbs (AR-711 and AR-713) that are directed against the
receptor binding domain of the SARS-CoV-2 virus. It is formulated
for delivery via inhalation using a nebulizer.
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, 2019
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:
Investor Relations
Jason Wong
Blueprint Life Science Group
jwong@bplifescience.com
(415) 375-3340 Ext. 4
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SOURCE Aridis Pharmaceuticals, Inc.