Top-Line Results Expected in the First Half of
2023
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced the completion of enrollment in the Phase 2 clinical
trial of the orally administered RASP modulator ADX-629, an
investigational new drug, for the treatment of chronic cough.
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In a preliminary study, RASP were
observed to be elevated in the bronchioalveolar lavage fluid of
patients with chronic cough. (Graphic: Aldeyra Therapeutics,
Inc.)
The multicenter, randomized, double-blind, placebo-controlled,
two-period Phase 2 crossover trial enrolled 51 patients with
refractory or unexplained chronic cough, which is often defined as
a cough that persists for more than eight weeks.1 Patients were
randomized to receive ADX-629 or placebo twice daily for 14 days,
followed by a 14-day washout period prior to crossing over to 14
days of treatment with ADX-629 or placebo, whichever was not
received in the first period. The primary endpoint of the trial is
safety. Secondary endpoints include awake cough frequency, 24-hour
cough frequency, patient-reported cough severity, quality of life,
and patient and clinician global impression of change. Top-line
results are expected in the first half of 2023.
“Chronic cough is a debilitating disease with dysregulated
immunological and neurosensory components that impair quality of
life,” stated Todd C. Brady, M.D., Ph.D., President and Chief
Executive Officer of Aldeyra. “Given the lack of FDA-approved
therapy, the unmet need for treatment is significant.”
ADX-629, an investigational new drug, is a novel, orally
administered RASP (reactive aldehyde species) modulator for the
potential treatment of systemic immune-mediated diseases. In a
preliminary study, RASP were observed to be elevated in the
bronchioalveolar lavage fluid of patients with chronic cough,2 and
may contribute to neurosensory dysfunction as well as inflammation.
By lowering RASP levels, ADX-629 potentially represents a novel
therapeutic approach with two distinct mechanisms of action.
ADX-629 has previously demonstrated activity in clinical trials of
patients with psoriasis, asthma, COVID-19, and alcohol
toxicity.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
diseases. Our approach is to develop pharmaceuticals that modulate
immunological systems, instead of directly inhibiting or activating
single protein targets, with the goal of optimizing multiple
pathways at once while minimizing toxicity. Our product candidates
include RASP (reactive aldehyde species) modulators ADX‑629,
ADX‑246, ADX‑248, and chemically related molecules for the
potential treatment of systemic and retinal immune-mediated
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
Review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of primary vitreoretinal lymphoma (under U.S. Food and
Drug Administration New Drug Application Priority Review),
proliferative vitreoretinopathy, and other rare sight-threatening
retinal diseases. 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, but not limited to, statements regarding the expected
timing of top-line results of the Phase 2 clinical trial of ADX-629
for the treatment of chronic cough and Aldeyra’s plans and
expectations for ADX-629. 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,”
“contemplates,” “likely,” “potential,” “continue,” “ongoing,”
“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, funding, and other factors that could delay the
initiation, enrollment, 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; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates, including as a result of
the FDA not accepting Aldeyra’s regulatory filings, requiring
additional clinical trials or data prior to review or approval of
such filings; 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 in clinical trials focused on the same or
different indications; 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
Aldeyra’s business, results of operations, and financial position;
uncertainty as to Aldeyra’s ability to commercialize (alone or with
others) and obtain reimbursement for 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 future revenue, the timing of
future revenue, the sufficiency or use of Aldeyra's cash resources
and needs for additional financing; 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 commercialization, marketing and manufacturing
capabilities and strategy; 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; political, economic, legal, social, and health risks,
including the COVID-19 pandemic and subsequent public health
measures, and war or other military actions, that may affect
Aldeyra’s business or the global economy; 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, 2022, which is on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at https://www.sec.gov/. Additional factors may be
described in those sections of Aldeyra's Quarterly Report on Form
10-Q for the quarter ended March 31, 2023, expected to be filed
with the SEC in the second quarter of 2023.
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 Kaplan AG. Chronic Cough in Adults: Make the Diagnosis and
Make a Difference. Pulm Ther. 2019 Jun;5(1):11-21. doi:
10.1007/s41030-019-0089-7. Epub 2019 Mar 13. PMID: 32026427; PMCID:
PMC6966942. 2 Data on file.
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Investor & Media Contact
Scott Solomon Sharon Merrill Associates, Inc. Senior Vice
President (857) 383-2409 ALDX@investorrelations.com
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