Live Webcast Scheduled to Begin 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 and
metabolic diseases, today announced advancement of new RASP
modulators and recent preclinical data in obesity in conjunction
with an Investor Roundtable scheduled to begin at 8:00 a.m. ET
today.
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the full release here:
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(Graphic: Aldeyra)
Pipeline Updates
- Following positive biomarker results in adults, including
near-normalization of lipid profiles, ADX-629, a first-in-class
orally administered investigational RASP modulator, advanced to the
pediatric cohort of the Phase 2 clinical trial in Sj�gren-Larsson
Syndrome, a rare inborn error of metabolism caused by mutations in
fatty aldehyde dehydrogenase and characterized by cognitive
dysfunction and skin disorders. Top-line results from approximately
five pediatric patients are expected in 2025.
- Based on new results in a preclinical model of obesity, novel
RASP modulator ADX-743 was advanced to Investigational New Drug
(IND)-enabling studies. ADX-743 is an analog of ADX-629, which has
demonstrated lowering of triglycerides and fatty acids in Phase 1
and Phase 2 clinical trials. Pending additional results, Aldeyra
expects to submit an IND application for ADX-743 or an alternative
RASP modulator for obesity or hypertriglyceridemia in 2025.
- Based in part on superior preclinical results in atopic
dermatitis and unprecedented exposure in preclinical RASP modulator
pharmacokinetic models, ADX-248 will be advanced in lieu of ADX-246
to Phase 1/2 clinical testing in atopic dermatitis. Phase 1
clinical testing of ADX-248 is expected to begin in the second half
of 2024.
- Novel RASP modulator ADX-631 has initiated preclinical testing
in models of retinal disease. ADX-631 is an analog of ADX-103,
which previously demonstrated activity in animal models of the dry
form of age-related macular degeneration (dry AMD), retinal
inflammation, and diabetic macular edema. Aldeyra expects to submit
an IND application for ADX-631 or an alternative RASP modulator for
the treatment of dry AMD or geographic atrophy in the first half of
2025.
“Consistent with the new data presented at our Research and
Development Day in April of this year, we continue to expand our
novel RASP modulator pipeline with the discovery and advancement of
new RASP modulators for the treatment of inflammatory and metabolic
diseases,” stated Todd C. Brady, M.D., Ph.D., President and CEO of
Aldeyra. “We look forward to discussing our recent progress on
today’s call with investors and are excited to share subsequent
updates on our pipeline throughout the remainder of 2024.”
Investor Roundtable Webcast Information
The 2024 Aldeyra Therapeutics Investor Roundtable will take
place at 8:00 a.m. ET today, Thursday, June 20, 2024. A live audio
webcast will be accessible from the “Investors & Media” section
of the Aldeyra website at https://ir.aldeyra.com/. A replay will be
available 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-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.
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 Aldeyra’s product candidates; the outcome and
expected timing and the results of Aldeyra’s planned preclinical
and clinical trials, including planned and ongoing trials; the
outcome and timing of the FDA’s review, acceptance and/or approval
of IND submissions for Aldeyra’s product candidates. 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/. Additional factors may
be described in those sections of Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2024, expected to be filed
with the SEC in the third 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/20240620180926/en/
Investor & Media Contact: David Burke Tel: (917)
618-2651 investorrelations@aldeyra.com
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