Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated and
metabolic diseases, today announced the clinical development plan
intended to enable resubmission of a New Drug Application (NDA) of
topical ocular 0.25% reproxalap, an investigational RASP modulator,
for the treatment of dry eye disease to the U.S. Food and Drug
Administration (FDA). Following discussions with the FDA, Aldeyra
intends to initiate a dry eye chamber clinical trial in the first
half of 2024. Contingent on positive results from the planned
clinical trial, NDA resubmission is expected in the second half of
2024. Based on FDA guidance, the planned review period for the
potential NDA resubmission is expected to be six months.
“The planned dry eye chamber clinical trial, if successful,
could represent the first pivotal demonstration of rapid
improvement in the symptoms of dry eye disease, a potentially
debilitating and increasingly pervasive condition that affects
millions of patients worldwide,” stated Todd C. Brady, M.D., Ph.D.,
President and Chief Executive Officer of Aldeyra.
In the proposed dry eye chamber trial, patients will be
administered vehicle (the drug product without the active
ingredient) before and during exposure to a dry eye chamber.
Qualifying patients will subsequently be randomized to receive
either reproxalap or vehicle before and during exposure to an
additional dry eye chamber. Approximately 100 patients are expected
to be enrolled to assess the primary endpoint of ocular discomfort.
The design and statistical powering for the proposed trial are
derived from four previously completed dry eye chamber clinical
trials with reproxalap. Based on the data from the previous
clinical trials, when analyzed with the planned trial design and
statistical plan, ocular discomfort in the dry eye chamber
following treatment with reproxalap was statistically lower than
that of vehicle (p=0.0003). The planned clinical trial is expected
to be more than 90% powered to detect a difference between
treatment groups.
“Affecting hundreds of millions of people globally, dry eye
disease is a multifactorial progressive disease that impacts
quality of life,” stated Sumit Garg, M.D., Professor of
Ophthalmology at University of California Irvine. “We are excited
about the novel upstream mechanism of action of RASP modulation and
the potential to provide rapid relief of signs and symptoms of dry
eye.”
A clinical trial at a different dry eye chamber, in addition to
a traditional six-week field clinical trial, are expected to be
conducted in parallel with the planned clinical trial as part of a
comprehensive strategy designed to account for disease
heterogeneity and potential differences in clinical sites and
environment. Consistent with previously disclosed guidance and
based on the current operating plan, cash and cash equivalents of
$142.8 million as of December 31, 2023 are projected to be
sufficient to fund operations beyond 2026.
Conference Call & Webcast Information Aldeyra will
host a conference call at 8:00 a.m. ET today, March 28, 2024, to
discuss the clinical development plan for resubmission of the new
drug application for reproxalap in dry eye disease. The dial-in
numbers are (833) 470-1428 for domestic callers and (404) 975-4839
for international callers. The access code is 515106. 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 and metabolic diseases. Our approach is to
develop pharmaceuticals that modulate protein 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 and metabolic diseases. Our late-stage
product candidates are reproxalap, a RASP modulator for the
potential treatment of dry eye disease and allergic conjunctivitis,
and ADX-2191, a novel formulation of intravitreal methotrexate for
the potential treatment of retinitis pigmentosa.
About Reproxalap Reproxalap is an investigational new
drug candidate in development for the treatment of dry eye disease
and allergic conjunctivitis, two of the largest markets in
ophthalmology. Reproxalap is a first-in-class small-molecule
modulator of RASP, which are elevated in ocular and systemic
inflammatory diseases. The mechanism of action of reproxalap has
been supported by the demonstration of statistically significant
and clinically relevant activity in multiple physiologically
distinct late-phase clinical indications. Reproxalap has been
studied in more than 2,400 patients with no observed safety
concerns; mild and transient instillation site irritation is the
most commonly reported adverse event in clinical trials.
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 reproxalap;
the outcome and expected timing and the results of Aldeyra’s
planned clinical trials; the outcome and timing of the FDA’s
review, acceptance and/or approval of a NDA resubmission for
reproxalap and the adequacy of the data included in the original
NDA and the potential NDA resubmission; and Aldeyra’s projected
cash runway. 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, issuing a complete response letter,
or requiring additional clinical trials or data prior to review or
approval of such filings or in connection with resubmissions 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;
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,
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, 2023, 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, 2024, expected to be filed
with the SEC in the second quarter of 2024, and Aldeyra’s other
filings with the SEC.
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/20240327454257/en/
Investor & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
Aldeyra Therapeutics (NASDAQ:ALDX)
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