Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), 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, today announced enrollment of the
first patient in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap
ophthalmic solution for the treatment of dry eye disease.
The multi-center randomized, double-masked, parallel design,
vehicle-controlled clinical trial will assess the efficacy and
safety of reproxalap compared to vehicle in objective sign
endpoints of dry eye disease, including tear RASP (reactive
aldehyde species) levels after single and multiple doses, and after
exposure to a dry eye chamber; Schirmer test (tear volume)
following a single dose; and conjunctival redness in the dry eye
chamber over 90 minutes. A run-in cohort of 20 patients is expected
to be completed this year. Results from the run-in will be used to
power the main cohort of the trial, and will confirm primary and
secondary endpoints.
“Initiation of the Phase 3 TRANQUILITY Trial, the first trial
designed to characterize the acute effects of reproxalap on RASP
and other objective signs of dry eye disease, marks another
important step toward a planned NDA submission in dry eye disease
by the end of 2021,” said Todd C. Brady, M.D., Ph.D. “For the more
than 30 million U.S. patients with dry eye disease, we believe that
reproxalap has the potential to fulfill significant unmet need as a
treatment with rapid onset of action and durable symptom
control.”
About Reproxalap
Reproxalap is a novel small-molecule immune-modulating covalent
inhibitor of RASP (reactive aldehyde species), which are elevated
in ocular and systemic inflammatory disease. Reproxalap’s mechanism
of action has been validated with the demonstration of
statistically significant and clinically relevant activity in
multiple physiologically distinct late-phase clinical indications.
Reproxalap is currently in Phase 3 clinical development as a 0.25%
ophthalmic solution for the treatment of dry eye disease and
allergic conjunctivitis, two ocular inflammatory diseases that
often occur together in the same patient.
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to
affect 34 million or more adults in the United States.1 The disease
is characterized by insufficient moisture and lubrication in the
anterior surface of the eye, leading to dryness, inflammation,
pain, discomfort, irritation, diminished quality of life, and in
severe cases, permanent vision impairment. Among physicians and
patients, existing therapy for dry eye disease is generally
regarded as inadequate and often requires weeks or months to
demonstrate activity. In patients with dry eye disease,
pro-inflammatory RASP may contribute to ocular inflammation and
changes in tear lipid composition. By diminishing RASP levels,
Aldeyra’s lead RASP inhibitor reproxalap represents a novel and
differentiated approach for the treatment of the symptoms and signs
of dry eye disease.
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 timing and projected enrollment
of the Phase 3 TRANQUILITY Trial of reproxalap, the submission of a
new drug application (NDA) in dry eye disease and the potential
utility of reproxalap as a treatment of dry eye disease. 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 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.
1 Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the
beaver dam offspring study: prevalence, risk factors, and
health-related quality of life. Am J Ophthalmol.
2014;157(4):799-806. doi:10.1016/j.ajo.2013.12.023.
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version on businesswire.com: https://www.businesswire.com/news/home/20201208005379/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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