Aridis
Pharmaceuticals, Inc. (NASDAQ:
ARDS), a biopharmaceutical company
focused on the discovery and development of novel anti-infective
therapies for treating life-threatening infections, today announced
the closing of patient enrollment in the multiple ascending dose
(MAD) and dose-ranging cohorts in the Phase 2a clinical trial of
AR-501 in cystic fibrosis (CF) patients. The Company is on track to
complete database lock, data analyses, and disclose top-line data
in the first quarter of 2023.
The Phase 2a study enrolled 39 CF patients from
24 clinical centers in the US. The CF patients were randomized and
treated in 4 cohorts; 3 cohorts received three weekly multiple
ascending doses of active drug at 6.4 mg, 20 mg and 40 mg or
placebo, while the 4th Cohort being dose-ranging with subjects
randomized to three weekly doses of AR-501 6.4 mg, 20 mg, or 40 mg,
or placebo. CF subjects were followed for 28 days after last
study dose for safety and pharmacokinetics (PK) of
inhaled AR-501. Aridis previously reported positive Phase 1 safety
data in June 2020 in healthy adults who were exposed to either a
single ascending dose (SAD) regimen or a multiple ascending dose
(MAD) regimen.
“We worked diligently through the pandemic to
enroll patients and are very pleased to reach this key milestone
for our Phase 2a study of AR-501 in CF patients.”
commented Aridis' Chief Medical Officer Hasan Jafri, MD. “Our
focus is now on data gathering from the clinical trial centers. We
anticipate reporting top-line results in the first quarter of
2023.”
AR-501 is being developed in collaboration with
the Cystic Fibrosis Foundation (CFF) and has been granted
Orphan Drug Designation (ODD), Fast Track, and Qualified
Infectious Disease Product (QIDP) designations by the US Food and
Drug Administration (FDA). In addition, the European Medicines
Agency (EMA) granted ODD to AR-501.
About
AR-501
AR-501 is an inhalable broad-spectrum
anti-infective currently under development for controlling
debilitating chronic lung infections in CF patients. AR-501
functions as an iron analog, which is a mechanism of action that is
distinct from antibiotics, and has broad antimicrobial activity
against several common bacterial, fungal, and mycobacterial species
are sometimes found to colonize the lungs of CF patients. The
current study is a randomized, double-blind, placebo-controlled
Phase 2a trial investigating the safety and pharmacokinetics of
multiple ascending doses of inhaled AR-501 in CF patients with
chronic bacterial lung infections. Based on available blinded
safety data of the on-going Phase 2a study, FDA concurred with the
Company’s proposal to include an optional higher dose cohort after
enrollment of the current dose cohorts.
About Cystic Fibrosis
Cystic Fibrosis (CF) is a genetic disorder
caused by mutations in the CF transmembrane conductance regulator
(CFTR) protein. This leads to numerous medical problems, including
abnormal airway secretions, mucus accumulation, and opportunistic
bacterial infections. Pseudomonas aeruginosa is the most
significant pathogen, with > 80% of CF patients becoming
chronically infected with P. aeruginosa by 18 years of
age. Also of increasing prevalence in CF patients are infections
caused by Staphylococcus aureus and non-tuberculosis
mycobacterium (NTM). Extensive antibiotic treatment has led to
selection of resistant strains, which are less responsive to drug
treatment and exacerbate disease progression.
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
SheldonRedChip Companies Inc. Matt@redchip.com1-917-280-7329
Investor RelationsDave
GentryRedchipDave@redchip.com1-800-733-2447
SOURCE Aridis Pharmaceuticals, Inc.
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