SAN JOSE, Calif., June 27, 2019 /PRNewswire/ -- Aridis
Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical
company focused on the discovery and development of targeted
immunotherapies for life-threatening bacterial infections,
announced today that the U.S. Food and Drug Administration
(FDA) has granted orphan drug designation to AR-501, the
Company's inhaled formulation of gallium citrate for treatment of
lung infection in patients with cystic fibrosis.
Cystic fibrosis patients often suffer from severe, persistent
secondary bacterial lung infections due to their underlying lung
disease which results in an immune-compromised state. AR-501 is a
non-antibiotic, small molecule anti-infective in which gallium
functions as an iron analog that antagonizes multiple
iron-dependent pathways in microbes and thus, subverts multiple key
functions in bacteria. Preclinical efficacy and safety data have
demonstrated that AR-501 works synergistically with multiple
antibiotics, is effective against antibiotic resistant strains, and
has a low intrinsic resistance profile. AR-501 is being developed
as a self-administered, weekly treatment which is being evaluated
in an-going Phase 1/2a clinical trial funded by the Cystic Fibrosis
Foundation (ClinicalTrials.gov Identifier: NCT03669614). The
Company expects to report data from the Phase 1 portion of the
trial which consists of healthy subjects in Q1 2020 and the Phase
2a segment with cystic fibrosis subjects in Q2 2021.
"We are pleased to receive the Orphan Drug Designation for
AR-501. This candidate diversifies our portfolio of novel
non-antibiotic anti-infective therapies and potentially provides a
novel, convenient treatment option for cystic fibrosis patients to
manage their chronic, life-long lung infections," commented Vu
Truong, PhD, Chief Executive Officer of Aridis Pharmaceuticals,
Inc.
The FDA's Office of Orphan Products Development (OOPD) advances
the evaluation and development of products that demonstrate promise
for the diagnosis and/or treatment of rare diseases or conditions
that affect fewer than 200,000 people in the U.S. The OOPD
evaluates scientific and clinical data submissions from sponsors to
identify and designate products as promising for rare diseases and
to further advance scientific development of such promising medical
products. Orphan drug designation provides incentives for sponsors
to develop products for rare diseases. These incentives may include
a partial tax credit for certain clinical trial expenditures, the
waiver of certain FDA user fees, and if approved, potential
eligibility for seven years of orphan drug marketing
exclusivity.
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 developing a non-antibiotic novel mechanism small
molecule anti-infective candidate to treat lung infections in
cystic fibrosis patients. The Company also utilizes its proprietary
MabIgX® technology platform to rapidly identify rare, potent
antibody-producing B-cells from patients who have successfully
overcome an infection to produce mAbs. These mAbs are already of
human origin and functionally optimized for high potency by the
donor's immune system, hence they do not require genetic
engineering or further optimization to achieve full functionality
and high mAb productivity. MabIgX® also allows for the selection of
any antibody isotype depending on the optimal effector function
required for treating the target infection. By bypassing the
humanization and binding sequence optimization steps, and the
entire process of generation of genetically engineered antibody
producing cell lines, MabIgX® enables high gross-margins and
expedited progression to clinical development.
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). 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 broad spectrum antibiotics, which is
the current standard of care. 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 company's
pipeline is highlighted below:
Aridis' Pipeline
AR-301 (ventilator
associated pneumonia). AR-301 is a fully human immunoglobulin
1, or IgG1, mAb currently in Phase 3 clinical development targeting
gram-positive S. aureus alpha-toxin in
ventilator-associated pneumonia, or VAP, patients.
AR-105 (ventilator associated
pneumonia). AR-105 is a fully human IgG1 mAb targeting
gram-negative P. aeruginosa alginate in
VAP patients. AR-105 is currently being evaluated in a global
Phase 2 clinical study.
AR-101 (hospital acquired pneumonia). AR-101 is
a fully human immunoglobulin M, or IgM, mAb targeting P.
aeruginosa liposaccharide serotype O11, which accounts for
approximately 22% of all P. aeruginosa hospital
acquired pneumonia cases worldwide. A plan for the next clinical
study will be communicated following the availability of Phase 2
clinical data for AR-105.
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 a Phase
1/2a clinical study in healthy volunteers and CF patients.
AR-401 (blood stream infections). AR-401 is a
fully human mAb currently in preclinical development aimed at
treating infections caused by gram-negative Acinetobacter
baumannii.
AR-201 (RSV infection). AR-201 is a fully human IgG1
mAb currently in preclinical development 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 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 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, 2018 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.