New Drug Application Resubmission
Anticipated in 2024
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 achievement of the primary
endpoint in a Phase 3 randomized, double-masked, vehicle-controlled
dry eye chamber clinical trial of 0.25% reproxalap ophthalmic
solution, an investigational new drug candidate, for the treatment
of dry eye disease. Reproxalap was statistically superior to
vehicle for the prespecified primary endpoint of ocular discomfort
(P=0.004), a U.S. Food and Drug Administration (FDA)-accepted
symptom of dry eye disease.
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“To our knowledge, the results announced today represent the
first positive Phase 3 clinical trial in a dry eye chamber with a
symptom as a primary endpoint, and we believe that the results are
supportive of the potential rapid clinical effect of reproxalap on
reducing the ocular discomfort associated with dry eye disease,”
stated Todd C. Brady, M.D., Ph.D., President and Chief Executive
Officer of Aldeyra.
In the Phase 3 clinical trial, patients were administered
vehicle (the drug product without the active ingredient) before and
during exposure to a dry eye chamber in a manner that Aldeyra
believes is consistent with the FDA’s dry eye disease draft
guidance1. Qualifying patients were subsequently randomized to
receive either reproxalap or vehicle before and during exposure to
an additional dry eye chamber. Of the 132 patients randomized, 66
patients received reproxalap and 66 patients received vehicle. The
primary endpoint was ocular discomfort, an FDA-accepted symptom of
dry eye disease, from 80 to 100 minutes in the chamber. The dry eye
chamber clinical trial was designed to satisfy the FDA’s New Drug
Application (NDA) resubmission requirement, identified in the
previously received complete response letter, of “at least one
additional adequate and well-controlled study to demonstrate a
positive effect on the treatment of ocular symptoms of dry eye.”
Through the FDA Special Protocol Assessment process and additional
comments, the FDA provided feedback on the clinical trial protocol
and statistical plan.
To Aldeyra’s knowledge, in patients with dry eye disease,
reproxalap is the first investigational drug with pivotal data
supportive of acute and chronic activity in reducing symptoms, and
the first investigational drug for chronic administration with
pivotal data supportive of acute activity in reducing ocular
redness. The potential NDA resubmission is anticipated in 2024.
Based on FDA guidance, the resubmission NDA review period is
expected to be six months.
There were no safety signals observed in the clinical trial, and
reproxalap was observed to be well tolerated. Consistent with prior
clinical trials, the most commonly reported adverse event was mild
and transient instillation site discomfort. No treatment-related
discontinuations were reported. Reproxalap has now been studied in
over 2,500 patients.
Conference Call & Webcast Information Aldeyra will
host a conference call at 9:00 a.m. ET today, August 8, 2024, to
discuss the Phase 3 dry eye chamber trial results and the plan for
resubmission of the NDA for reproxalap in dry eye disease. The
dial-in numbers are (888) 596-4144 for domestic callers and (646)
968-2525 for international callers. The access code is 7321123. 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-248, ADX-743, ADX-631, 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 2,500 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 timing of the FDA’s review, acceptance and/or
approval of a potential NDA resubmission for reproxalap and the
adequacy of the data included in the original NDA and such NDA
resubmission; and Aldeyra’s expectations regarding the labeling for
reproxalap, if approved. 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, and
Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2024, 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.
1 www.fda.gov/media/144594/download
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version on businesswire.com: https://www.businesswire.com/news/home/20240808408806/en/
Investor & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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