ADX-246 for Systemic Immune-Mediated Diseases
and ADX-248 for Geographic Atrophy Build on Aldeyra’s Drug
Discovery and Development Engine Targeting RASP Modulation
New Product Candidates Highlight Aldeyra’s
Clinical Indication Expansion to Systemic and Retinal Diseases
Characterized by Inflammation
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced the advancement of two investigational new drug
candidates, ADX‑246 and ADX‑248, to clinical testing, pending
completion of U.S. Food and Drug Administration Investigational New
Drug (IND) requirements. ADX‑246 and ADX‑248 represent the most
recent group of product candidates generated from Aldeyra’s
systems-based drug discovery and development engine focused on
novel RASP modulators designed to decrease immune responses that
lead to disease. Pending completion of the IND requirements, a
Phase 1 clinical trial of orally administered ADX‑246 for the
treatment of systemic immune-mediated diseases, and a Phase 1/2
clinical trial of intravitreally injected ADX‑248 for the treatment
of geographic atrophy, a sight-threatening retinal disease, are
expected to initiate in the second half of 2023 or early 2024.
“Highlighting Aldeyra’s expansion to treatment of diseases that
affect the retina and other areas of the body, ADX-246 and ADX-248
further support Aldeyra’s position as a leader in RASP modulation,
a novel pharmacology that potentially addresses a broad array of
diseases characterized by inflammation,” stated Todd C. Brady,
M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Few
safe, broadly active, orally administered therapeutic options are
available for the treatment of systemic immune-mediated diseases,
and only a single drug is approved for the treatment of geographic
atrophy.”
ADX-246 is designed to treat immune-mediated systemic diseases
thought to be caused or exacerbated by pro-inflammatory RASP.
ADX-246 is one of the most potent RASP modulators developed by
Aldeyra and has demonstrated activity following systemic
administration in animal models of sepsis, hepatitis, and atopic
dermatitis.
ADX-248 is designed to reduce the inflammation and
macromolecular aggregate formation associated with geographic
atrophy, a severe form of macular degeneration. Pro-inflammatory
RASP are associated with inflammation in geographic atrophy and
potentially contribute to visual impairment in low-light settings
early in the course of the disease. Further, retinaldehyde, a
well-described RASP associated with retinal disease, leads to the
formation of macromolecular aggregates that comprise, in part,
retinal inclusions characteristic of geographic atrophy and related
diseases, including Stargardt disease and the dry form of
age-related macular degeneration.
In aggregate, more than 100 million individuals in the United
States may be impacted by diseases associated with systemic
inflammation.1 Geographic atrophy, a leading cause of blindness,
affects more than 1 million people in the United States.2
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company
developing innovative therapies designed to treat immune-mediated
diseases. Our approach is to discover and develop pharmaceuticals
that modulate immunological 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
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of primary vitreoretinal lymphoma (under U.S. Food and
Drug Administration New Drug Application review), proliferative
vitreoretinopathy, and other rare sight-threatening retinal
diseases. For more information, visit https://www.aldeyra.com/ and
follow us on LinkedIn, Facebook, and Twitter.
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 expected timing of initiating
clinical trials of ADX-246 for systemic immune-mediated diseases
and ADX-248 for geographic atrophy. 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,” “on schedule,” “target,” “design,” “estimate,” “predict,”
“potential,” “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, 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; updated or
refined data based on Aldeyra's continuing or post-hoc review and
quality control analysis of clinical data, Aldeyra's ability to
design clinical trials with protocols, data analysis methodologies,
and endpoints acceptable to applicable regulatory authorities;
delay in or failure to obtain regulatory approval of Aldeyra's
product candidates; 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 on
different indications; the risk that the results from earlier
clinical trials, portions of clinical trials, or pooled clinical
data may not accurately predict results of subsequent trials or the
remainder of a clinical trial; 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 revenue,
the sufficiency or use of Aldeyra's cash resources and needs for
additional financing; political, economic, legal, social, and
health risks, including the COVID-19 pandemic and subsequent public
health measures, and war or other military actions, that may affect
Aldeyra’s business or the global economy; 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 limited sales and marketing infrastructure; 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; 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, 2021, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2022, 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 Annual
Report on Form 10-K for the year ended December 31, 2022, expected
to be filed with the SEC in the first quarter of 2023.
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
https://www.ncbi.nlm.nih.gov/books/NBK493173/; updated August 8,
2022. 2 Lancet Global Health. 2(2):e106-16, 2014.
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Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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