AR-701 is effective in vitro against
SARS-CoV-2 Omicron subvariants, including BA.4 and BA.5
LOS
GATOS, Calif., Aug. 10,
2022 /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 inhaled
treatment of its fully human monoclonal antibody cocktail AR-701
resulted in no detectable SARS-CoV-2 virus in the lungs of infected
rhesus macaques, and protected their lungs from disease. AR-701 was
effective in the non-human primates when used either as a
prophylactic or therapeutic treatment regimen.
- Therapeutic administration of inhaled AR-701 substantially
reduced and continued to suppress the viral load in the nasal sinus
and oropharynx (upper respiratory tract region) for the entire
5-day testing period.
- Additional lab research also indicates both mAbs in the AR-701
cocktail are effective against the SARS-CoV-2 Omicron BA.1, BA.2,
BA.4, BA.5 subvariants in vitro.
This non-human primate research was conducted through a
collective effort involving researchers at the Oregon National
Primate Research Center (ONPRC) at Oregon Health & Science
University (OHSU), the University of
California at Davis, Vanderbilt
University, the University of
California at Irvine, and Aridis, with a grant supplement to
OHSU from the National Institutes of Health's Office of Research
Infrastructure Programs in the Office of the Director (OD, PHS
grant P51 OD011092). Preliminary study results were recently
presented at the Immunotherapy for Infectious Diseases Conference
2022 in Pavia, Italy. Additional
data are being analyzed and will be submitted to a peer-reviewed
scientific journal for publication.
"An efficacy demonstration in non-human primates has been a key
milestone and a correlate for clinical success in human trials. The
observed strong prophylactic and therapeutic efficacy bodes well
for AR-701 and is an important step forward," commented
Vu Truong, Ph.D., CEO of Aridis
Pharmaceuticals. The proprietary inhaled formulation is designed to
deliver the mAbs directly to the site where the SARS-CoV-2 virus
initially infects, amplifies, and is transmitted from the infected
individual to others. "Given the challenges in maintaining
high vaccination coverage and a protracted COVID-19 pandemic, there
is a greater need to develop accessible, long-acting therapeutic
treatments, especially treatments that can also effectively block
person-to-person viral transmission. These data demonstrate that
the inhaled, self-administered dosage form of half-life extended
AR-701 is on track to meet this product profile," said 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. Each mAb of
the AR-701 cocktail neutralizes coronaviruses using a distinct
mechanism of action, namely inhibition of viral fusion and entry
into human cells (AR-703) or blockage of viral binding to the human
'ACE2' receptor (AR-720). The activity of the two mAbs complement
and enhance each other in a synergistic fashion, creating a potent
first-in-class cocktail. AR-720 binds to the 'receptor binding
domain' of the spike protein of SARS-CoV-2, while AR-703 binds to
the 'S2' stalk region of spike proteins from betacoronaviruses,
including the SARS-CoV-2 variants (Beta, Gamma, Delta, Epsilon, and
Omicron). Both mAbs bind to the Omicron subvariants, BA.1, BA.2,
BA.4, and BA.5 with comparable affinity compared to the original
Wuhan strain. All authentic live
SARS-CoV-2 beta, gamma, delta, epsilon, and Omicron variants, SARS,
and MERS tested were neutralized by both mAbs of AR-701 cocktail
in vitro. Multiple animal challenge models widely used
to evaluate COVID-19 treatments support the broad efficacy of
AR-701 against the original Wuhan
wildtype strain, the Delta variant, the Omicron variant, and the
severe acute respiratory syndrome virus (SARS). 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. Aridis Pharmaceuticals
recently received a grant from the Bill and Melinda Gates
Foundation to evaluate the prevention of influenza and SARS-CoV2
viral transmission using inhaled delivery of monoclonal
antibodies.
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 evaluated
in a Phase 3 clinical study as a preventative treatment of S.
aureus colonized mechanically ventilated patients who do not
yet have VAP.
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-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, 2021 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
SOURCE Aridis Pharmaceuticals, Inc.
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SOURCE Aridis Pharmaceuticals, Inc.
