- On track to complete data compilation and analyses, with
top-line data expected to be announced in December '22
LOS
GATOS, Calif., Oct. 4, 2022
/PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:
ARDS) announced today that patient enrollment is closed in the
AR-301 Phase 3 clinical study. The Company is on track to complete
database lock, data analyses, and expects to disclose top-line data
in December 2022. The AR-301-002
Phase 3 'ASAP-1' study compares the superiority of adjunctive use
of the investigational, targeted immunotherapy candidate AR-301
with standard of care (SOC) antibiotics versus SOC antibiotics
alone, for the treatment of ventilator associated pneumonia (VAP)
caused by Gram-positive bacteria Staphylococcus aureus
(S. aureus). Patients enrolled will complete their treatment
and 28-day follow-up per study protocol.
Safety and efficacy of the fully human monoclonal antibody
AR-301 (20 mg/kg infusion given once) are being evaluated using a
randomized, double-blinded, placebo-controlled, superiority
clinical trial design. The study was initiated as a globally
harmonized Phase 3 study after the design and primary endpoint of
clinical cure of pneumonia were reviewed by the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA). This
global study involved 153 clinical sites in 20 countries across
U.S., Latin and South Americas, Europe, and Asia. ASAP-1 is the first ever Phase 3
superiority clinical study evaluating immunotherapy with a human
monoclonal antibody to treat acute pneumonia.
"Following the protracted COVID-19 pandemic that has slowed the
pace of patient enrollment in clinical trials across the world, we
are pleased to reach this key milestone for the study. We are
working diligently to gather data from the clinical centers and
report top-line results of this landmark Phase 3 study," said
Aridis' Chief Medical Officer Hasan
Jafri, MD.
In the study, all patients received SOC antibiotics in
combination with either AR-301 immunotherapy or placebo by
intravenous infusion following the diagnosis of severe pneumonia
and confirmation of S. aureus in the patient's lung fluid, using
either the classical microbiology test and/or a rapid diagnostic
test. The primary endpoint of clinical cure of pneumonia is a
composite endpoint which comprises three objectively measured
outcomes that must be met for declaration of treatment success,
namely 1) survival, 2) removal of mechanical ventilation, and 3)
resolution of signs and symptoms of pneumonia. The ongoing Phase 3
study remains blinded. The independent Data Safety Monitoring
Committee, which has access to unblinded data, has not expressed
any safety concerns. ASAP-1 is the first of two Phase 3 studies
required for licensure. Details of the study can be reviewed on
www.clinicaltrials.gov website using Identifier
NCT03816956.
About AR-301
AR-301 is a fully human IgG1 monoclonal antibody that
specifically targets S. aureus alpha-toxin, an important
virulence factor that is secreted by both methicillin-resistant
S. aureus (MRSA) and methicillin-susceptible S.
aureus (MSSA). We believe that AR-301 protects against
alpha-toxin mediated destruction of host cells, preserving the
human immune cells. AR-301's mode of action is independent of the
antibiotic resistance profile of S. aureus and it is active
against infections caused by both MRSA and MSSA.
About Ventilator Associated Pneumonia (VAP) with S.
aureus Bacterial Infection
VAP poses serious challenges in the hospital setting, as
standard of care antibiotics are becoming inadequate in treating
infected patients. There are approximately 251,600 cases of
hospital acquired pneumonia reported in the U.S. annually caused by
S. aureus (Decision Resources Group 2016 data base). These
patients are typically at high risk of mortality, which is
compounded by other life threatening co-morbidities and rise in
antibiotic resistance. Epidemiology studies estimate that the
probability of death attributed to S. aureus ranges from 29%
to 55%. In addition, pneumonia infections can prolong patient stays
in ICUs (intensive care units) and the use of mechanical
ventilation, creating a major economic burden on patients, hospital
systems and payors. For example, ICU cost of care for a ventilated
pneumonia patient is approximately $10,000 per day, and the duration of ICU stay is
typically twice that of a non-infected ICU patient (Infection
Control and Hospital Epidemiology. 2010, vol. 31, pp. 509 515).
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 antibodies (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 typically 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 superiority 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 (CF) 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
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SOURCE Aridis Pharmaceuticals, Inc.