Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that it has received a Study May Proceed letter from the
U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical
trial evaluating ADX-629, a novel orally available reactive
aldehyde species (RASP) inhibitor, for the treatment of adult
patients hospitalized for COVID-19.
“The FDA’s clearance of our Investigational New Drug application
for Phase 2 testing in patients with COVID-19 is an important
milestone for ADX-629, which represents a new paradigm in the
treatment of immune-mediated diseases,” stated Todd C. Brady, M.D.,
Ph.D., President and CEO of Aldeyra. “The COVID-19 clinical trial
is part of a broad systemic disease strategy designed to
demonstrate ADX-629 proof of concept in serious inflammatory
diseases with critical medical need.”
The planned Phase 2 clinical trial is expected to enroll
approximately 30 patients with COVID-19. Patients will be enrolled
upon hospitalization for COVID-19 and treated with orally
administered ADX-629 or placebo twice-daily for up to 28 days. Key
endpoints will include the National Institute of Allergy and
Infectious Diseases COVID-19 scale and levels of cytokines and
RASP.
Additional proof of concept Phase 2a clinical trials of ADX-629
in psoriasis and atopic asthma are expected to initiate in the
fourth quarter of 2020. The timing of trial initiations depends, in
part, on restrictions related to COVID-19, the availability of
clinical research facilities and staffing, the ability to recruit
patients, and regulatory feedback.
About ADX-629
ADX-629 is a novel orally administered RASP inhibitor in Phase 2
clinical development for the treatment of immune-mediated diseases.
RASP inhibitors have the potential to represent upstream
immunological switches that modulate immune systems from
pro-inflammatory states to anti-inflammatory states. ADX-629 is a
member of the same chemical class as reproxalap, a RASP inhibitor
in Phase 3 clinical trials for dry eye disease and allergic
conjunctivitis, two common ocular inflammatory diseases.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target
reactive aldehyde species (RASP) which are elevated in ocular and
systemic inflammatory disease, and result in cytokine release via
activation of a broad array of inflammatory factors, including
NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being
evaluated in Phase 3 clinical trials in patients with dry eye
disease and allergic conjunctivitis, and ADX-629 is in Phase 2
clinical development for the treatment of systemic inflammatory
diseases. The company’s clinical pipeline also includes ADX-2191, a
dihydrofolate reductase inhibitor in Phase 3 testing for
proliferative vitreoretinopathy, and ADX-1612, a chaperome
inhibitor in development for COVID-19 and ovarian cancer. For more
information, visit https://www.aldeyra.com/ and follow us on
LinkedIn, Facebook, and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding Aldeyra's strategy, future
operations, prospects, plans, and objectives and Aldeyra's plans
and expectations for ADX-629 and its other product candidates.
Aldeyra intends such forward-looking statements to be covered by
the safe harbor provisions for forward-looking statements contained
in Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995. In some cases,
you can identify forward-looking statements by terms such as, but
not limited to, "may," "might," "will," "objective," "intend,"
"should," "could," "can," "would," "expect," "believe,"
"anticipate," "project," "on track," "scheduled," "target,"
"design," "estimate," "predict," "potential," "aim," "plan" or the
negative of these terms, and similar expressions intended to
identify forward-looking statements. Such forward-looking
statements are based upon current expectations that involve risks,
changes in circumstances, assumptions, and uncertainties. Aldeyra
is at an early stage of development and may not ever have any
products that generate significant revenue. All of Aldeyra's
development timelines may be subject to adjustment depending on
recruitment rate, regulatory review, preclinical and clinical
results, and other factors that could delay the initiation or
completion of clinical trials. As a result of the COVID-19
pandemic, clinical site availability, staffing, and patient
recruitment have been negatively affected and the timelines to
complete our clinical trials may be delayed. Important factors that
could cause actual results to differ materially from those
reflected in Aldeyra's forward-looking statements include, among
others, the timing of enrollment, commencement and completion of
Aldeyra's clinical trials, the timing and success of preclinical
studies and clinical trials conducted by Aldeyra and its
development partners; updated or refined data based on Aldeyra's
continuing review and quality control analysis of clinical data,
Aldeyra's ability to design clinical trials with protocols and
endpoints acceptable to applicable regulatory authorities; delay in
or failure to obtain regulatory approval of Aldeyra's product
candidates; the ability to maintain regulatory approval of
Aldeyra's product candidates, and the labeling for any approved
products; the risk that prior results, such as signals of safety,
activity or durability of effect, observed from preclinical or
clinical trials, will not be replicated or will not continue in
ongoing or future studies or trials involving Aldeyra's product
candidates; the scope, progress, expansion, and costs of developing
and commercializing Aldeyra's product candidates; the current and
potential future impact of the COVID-19 pandemic on our business,
results of operations and financial position; uncertainty as to
Aldeyra’s ability to commercialize (alone or with others) Aldeyra's
product candidates following regulatory approval, if any; the size
and growth of the potential markets and pricing for Aldeyra's
product candidates and the ability to serve those markets;
Aldeyra's expectations regarding Aldeyra's expenses and revenue,
the sufficiency or use of Aldeyra's cash resources and needs for
additional financing; political, economic, legal, social and health
risks, including the recent COVID-19 outbreak and subsequent public
health measures, that may affect Aldeyra’s business or the global
economy; the rate and degree of market acceptance of any of
Aldeyra's product candidates; Aldeyra's expectations regarding
competition; Aldeyra's anticipated growth strategies; Aldeyra's
ability to attract or retain key personnel; Aldeyra’s limited sales
and marketing infrastructure; Aldeyra's ability to establish and
maintain development partnerships; Aldeyra’s ability to
successfully integrate acquisitions into its business; Aldeyra's
expectations regarding federal, state and foreign regulatory
requirements; regulatory developments in the United States and
foreign countries; Aldeyra's ability to obtain and maintain
intellectual property protection for its product candidates; the
anticipated trends and challenges in Aldeyra's business and the
market in which it operates; and other factors that are described
in the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
Aldeyra's Annual Report on Form 10-K for the year ended December
31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, which are on file with the Securities
and Exchange Commission (SEC) and available on the SEC's website at
www.sec.gov.
In addition to the risks described above and in Aldeyra's other
filings with the SEC, other unknown or unpredictable factors also
could affect Aldeyra's results. No forward-looking statements can
be guaranteed, and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Aldeyra undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200909005338/en/
Corporate: David McMullin Aldeyra Therapeutics, Inc. Tel:
781-761-4904 ext. 218 dmcmullin@aldeyra.com Investor &
Media: Scott Solomon Sharon Merrill Associates, Inc. Tel:
617-542-5300 ALDX@investorrelations.com
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