Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced the initiation of Phase 2 clinical trials of ADX-629, a
first-in-class orally administered reactive aldehyde species (RASP)
inhibitor, for the treatment of COVID-19, atopic asthma, and
psoriasis as part of a systematic strategy to assess activity
across different types of immunological diseases. The Phase 2
clinical trials follow a successful Phase 1 clinical trial of
ADX-629, which demonstrated no treatment-related adverse events at
any dose tested, as well as target engagement evidenced by
statistically lower RASP levels in drug-treated subjects relative
to controls.
“The initiation of Phase 2 clinical testing of ADX-629, a
first-in-class orally administered RASP inhibitor, is an exciting
milestone for Aldeyra as we broaden the focus of our RASP platform
from ocular indications to systemic disease,” stated Todd C. Brady,
M.D., Ph.D., President and CEO of Aldeyra. “The Phase 2 clinical
trials announced today underscore our mission to develop new
therapies that improve patient outcomes by fine-tuning the body’s
immune response. Unlike traditional immunologic drugs, ADX-629 is
designed to modulate the immune system rather than shut down
singular molecular targets, an approach that may lead to
toxicity.”
COVID-19 – A Clinical Model of Cytokine Release
Syndrome
The multi-center, double-blind, placebo-controlled,
parallel-group Phase 2 clinical trial in COVID-19 will evaluate the
safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in
adult patients. Approximately 30 patients will be randomized to
receive either 300 mg of 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 plasma levels of
cytokines and RASP. Enrollment is expected to begin by
year-end.
Atopic Asthma – A Clinical Model of Allergic
Inflammation
The single-center, double-masked, placebo-controlled, crossover
Phase 2 clinical trial will assess the safety and efficacy of
ADX-629 in adult patients with mild asthma induced by bronchial
asthma challenge. Twelve patients with cat or house dust mite
allergen-induced asthma will be randomized to receive either 600 mg
of ADX-629 or placebo twice daily for approximately one week.
Outcomes will include pulmonary function testing following allergen
and methacholine challenge, sputum eosinophil counts, and plasma
levels of cytokines and RASP. Enrollment is expected to begin in
the first quarter of 2021.
Psoriasis – A Clinical Model of Autoimmune
Disease
The multi-center, open-label, single-group Phase 2 clinical
trial will assess the safety and efficacy of ADX-629 in adult
patients with mild to moderate plaque psoriasis. Ten adult patients
will receive 250 mg of ADX-629 twice daily for up to 90 days.
Outcomes will include psoriasis area and severity index, skin
cytokine transcription profiles, plasma leukocyte cytokine release
following endotoxin-challenge, and plasma levels of cytokines and
RASP. Enrollment is expected to begin in the first half of next
year.
“We believe that ADX-629 has broad applicability to systemic
immune-mediated diseases,” Dr. Brady said. “We look forward to
characterizing more fully the immune modulating activity of ADX-629
in multiple types of severe inflammation.”
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 potentially 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 RASP
(reactive aldehyde species), 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. 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 the initiation and enrollment of
Phase 2 clinical trials of ADX-629 in COVID-19, atopic asthma, and
psoriasis. 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. 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
clinical trials involving Aldeyra's product candidates; the scope,
progress, expansion, and costs of developing and commercializing
Aldeyra's product candidates; 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 September 30, 2020, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at https://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/20201217005223/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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