Clinical Results and Potential New Drug
Application Submission Expected in the Second Half of 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 enrollment of the first patient
in a Phase 3 dry eye chamber clinical trial designed to enable a
potential resubmission of the New Drug Application (NDA) of topical
ocular 0.25% reproxalap, an investigational RASP modulator, for the
treatment of dry eye disease.
Contingent on positive results from the clinical trial, Aldeyra
expects to resubmit the NDA of reproxalap for the treatment of dry
eye disease to the U.S. Food and Drug Administration (FDA) in the
second half of 2024. Aldeyra intends to include in the potential
NDA resubmission a draft label describing chronic and acute
improvement in symptoms and ocular redness. To Aldeyra’s knowledge,
the draft label could represent the first dry eye disease label
that incorporates clinical data assessed acutely in a dry eye
chamber, and potentially the first dry eye disease label that
includes reduction in ocular redness for a chronically administered
drug. Per FDA guidance, the planned review period for the potential
NDA resubmission is expected to be six months.
In the clinical trial, patients are administered vehicle (the
drug product without the active ingredient) before and during
exposure to a dry eye chamber. Qualifying patients are subsequently
randomized to receive either reproxalap or vehicle before and
during exposure to an additional dry eye chamber. Approximately 110
patients are expected to be enrolled to assess the primary endpoint
of ocular discomfort. In four previously completed dry eye chamber
clinical trials of reproxalap, when analyzed in aggregate with the
trial design and statistical plan recently discussed with the FDA,
ocular discomfort in the dry eye chamber following treatment with
reproxalap was statistically lower than that of vehicle
(p=0.0003).
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 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,
cash equivalents, and marketable securities of $133.0 million as of
March 31, 2024 are projected to be sufficient to fund operations to
beyond the end of 2026.
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 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.
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, including planned and
ongoing clinical trials for reproxalap; 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; Aldeyra’s
expectations regarding the labeling of reproxalap, if approved; 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, and
Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended March
31, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240508055946/en/
Investors & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
Aldeyra Therapeutics (NASDAQ:ALDX)
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