- Relative to Placebo, Statistical Significance Achieved for
Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough
Frequency (P=0.001), Awake Cough Count (P=0.001), and 24‑Hour Cough
Count (P=0.001)
- ADX-629 Was Well Tolerated and No Safety Concerns Were
Identified
- Company to Discuss Results in Conference Call and Webcast at
8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated diseases,
today announced positive top-line results from the Phase 2 clinical
trial of orally administered ADX‑629, an investigational new
drug, in patients with chronic cough. The clinical trial
demonstrated statistically significant reduction in cough frequency
following administration of ADX‑629 relative to placebo.
“Consistent with previously demonstrated activity in clinical
trials of patients with psoriasis, asthma, and COVID-19, the
reduction in cough frequency observed in the Phase 2 clinical trial
in chronic cough supports the potentially broad-based activity of
ADX‑629 as a novel, immune-modulating therapeutic approach,”
stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
“We look forward to discussing the results with regulatory
authorities as we consider the expansion of clinical testing to
include patients with co-morbid conditions of frequent coughing and
active inflammation.”
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 and is unresponsive
to treatment. 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 clinical trial was safety.
Secondary endpoints included awake cough frequency (the key
secondary endpoint), 24-hour cough frequency, quality of life, and
clinical impression scales.
Fifty-one patients were enrolled, and all patients completed
both treatment periods. Relative to placebo, statistical
significance was achieved for the key secondary endpoint of
reduction in awake cough frequency (P=0.01), the secondary endpoint
of 24-hour cough frequency (P=0.001), and the related post-hoc
analyses of awake cough count (P=0.001) and 24-hour cough count
(P=0.001). Quality of life and clinical impression scales did not
consistently change between treatment groups over the two-week
treatment periods. ADX‑629 was well tolerated, and no safety
concerns were identified following administration of either
ADX‑629 or placebo. No serious adverse events were reported,
adverse event frequencies were similar across treatment groups, and
no patients discontinued due to adverse events.
“Frequent coughing, which is characteristic of a number of
inflammatory pulmonary diseases, represents a persistently
disturbing condition for patients,” stated Gary N. Gross, MD.,
Clinical Professor of Internal Medicine at Southwestern Medical
School and a Board-certified allergist and immunologist with the
Dallas Allergy & Asthma Center. “The difficulty in treating
chronic coughing highlights the medical need for new
therapies.”
Consistent with a Phase 1 clinical trial and the Phase 2
clinical trial in psoriasis, improvement in LDL and HDL levels was
observed following treatment with ADX‑629 relative to
treatment with placebo. 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. ADX‑629 is also currently in
development for atopic dermatitis, idiopathic nephrotic syndrome,
and Sj�gren-Larsson Syndrome. Initial results from each trial are
expected in the second half of 2023. A Phase 2 clinical trial of
ADX‑629 in moderate alcohol-associated hepatitis is expected
to initiate in the second half of 2023.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to
discuss top-line results of the Phase 2 clinical trial of
ADX‑629 in chronic cough. The dial-in numbers are (888)
415‑4305 for domestic callers and (646) 960‑0336 for international
callers. The access code is 5858366. A live webcast of the
conference call will be available on the Investor Relations page of
the company’s website at https://ir.aldeyra.com. After the live
webcast, the event will remain archived on the Aldeyra Therapeutics
website for 90 days.
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 proliferative vitreoretinopathy and retinitis
pigmentosa.
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 Aldeyra’s
future expectations, plans, and prospects, including without
limitation statements regarding: the goals, opportunity and
potential for ADX‑629 and anticipated clinical or regulatory
milestones 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,” “on schedule,” “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 may 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, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023, which are 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 June 30, 2023, expected to be filed
with the SEC in the third 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230627747185/en/
Investors & Media:
David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
Aldeyra Therapeutics (NASDAQ:ALDX)
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