Live Webcast Scheduled to Begin at 9 am EDT
Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host
the Aldeyra 2024 Research & Development Day with investors and
financial analysts in New York City to present recent pipeline
developments relating to the RASP modulation platform and ADX-2191
for the treatment of retinitis pigmentosa.
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the full release here:
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(Graphic: Aldeyra Therapeutics)
Aldeyra will present new preclinical data from investigational
RASP modulators in animal models for obesity, atopic dermatitis,
inflammatory pain, and alcoholic hepatitis. In the diet-induced
model of obesity, ADX-629 decreased weight and fat mass alone and
in combination with a GLP-1 agonist. In the oxazolone model of
atopic dermatitis, RASP modulators ADX-629, ADX-246, and ADX-248
demonstrated activity in reducing skin thickness and erosion, and
in reducing spleen to body weight ratio. In the carrageenan model
of inflammatory pain, ADX-246 increased tolerance to mechanical and
thermal pain, and decreased joint swelling. Consistent with
previously released data from ADX-629 in a model of alcoholic
hepatitis, ADX-246 reduced levels of fibrosis and fat in liver.
“The new data released today support the expansion of our novel
RASP platform into clinical indications that may include
fat-mass-targeted weight loss and inflammatory pain, highlighting
the breadth of potential product candidate opportunities afforded
by modulating RASP levels,” stated Todd C. Brady, M.D., Ph.D.,
President and CEO of Aldeyra.
Based on recent discussions with the U.S. Food and Drug
Administration (the FDA), Aldeyra intends to initiate a potentially
pivotal Phase 2/3 clinical trial of investigational product
candidate ADX-2191 (methotrexate injection, USP) in patients with
retinitis pigmentosa due to rhodopsin misfolding mutations. The
potential activity of ADX-2191 in retinitis pigmentosa is supported
by results from a Phase 2 clinical trial, announced in 2023, which
demonstrated improvements from baseline in retinal sensitivity
following treatment. An overview of the unmet medical need in
retinitis pigmentosa will be provided by Ramiro Maldonado, M.D.,
Principal Investigator of the Phase 2 clinical trial and Assistant
Professor of Ophthalmology, Vitreoretinal Diseases, and Surgery at
Duke University.
“Due to loss of vision and dramatic impact on quality of life,
retinitis pigmentosa remains a highly significant unmet medical
need in retinal disease,” stated Dr. Maldonado. “Even with the
advent of gene therapy, cell therapy, and other new approaches not
yet approved by the FDA for treatment, a safe and effective drug
that could slow the progression of retinitis pigmentosa is in
critical demand.”
Research & Development Day Webcast Information
Aldeyra’s Research & Development Day will take place from 9:00
am to 1:00 pm EDT today, Thursday, April 25, 2024, in New York
City. A live audio webcast and slide presentation will be
accessible from the “Investors & Media” section of the Aldeyra
website at https://ir.aldeyra.com/ for 90 days following the
event.
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,
ADX-2191, and other product candidates; the outcome and expected
timing and the results of Aldeyra’s planned clinical trials,
including planned and ongoing clinical trials for reproxalap and
ADX-2191; 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 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/20240425445928/en/
Investor & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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