Top-Line Results Expected in the First Half of
2023
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced the completion of enrollment in the Phase 2 clinical
trial of ADX‑2191 (methotrexate injection, USP), an investigational
drug candidate, for the treatment of retinitis pigmentosa, a group
of rare genetic eye diseases characterized by retinal cell death
and loss of vision, for which there is no U.S. Food and Drug
Administration (FDA)-approved treatment.
The open-label, single-center Phase 2 clinical trial enrolled a
total of eight retinitis pigmentosa patients with rhodopsin gene
mutations, including the P23H gene mutation. Patients receive
either monthly or twice-monthly intravitreal doses of ADX‑2191 for
three months. The primary endpoint of the trial is safety.
Secondary endpoints include change from baseline in visual acuity;
retinal function, as assessed by foveal microperimetry,
electroretinography, and dark adaptation; and retinal morphology,
as assessed by optical coherence tomography.
“Given the lack of FDA-approved therapies for retinitis
pigmentosa, a sight-threatening group of diseases that affect more
than one million patients worldwide, novel therapeutic approaches
are in demand,” stated Todd C. Brady, M.D., Ph.D., President and
Chief Executive Officer of Aldeyra. “Aldeyra is committed to
working with patients and physicians to attempt to ameliorate the
unrelenting burden of retinitis pigmentosa, and we look forward to
reporting top-line results of the Phase 2 clinical trial in the
first half of this year.”
About ADX-2191
ADX-2191 is a novel intravitreal formulation of methotrexate,
which in preclinical models of retinitis pigmentosa facilitates the
clearance of misfolded rhodopsin, a critical visual cycle protein
susceptible to genetic mutation.1 The prevalence of retinitis
pigmentosa is more than one million people worldwide, and genetic
mutations leading to rhodopsin misfolding account for approximately
one-third of cases. ADX-2191 has been granted orphan drug
designation by the U.S. Food and Drug Administration for the
treatment of retinitis pigmentosa.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
diseases. Our approach is to 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 the expected
timing of top-line results of the Phase 2 clinical trial of
ADX-2191 in retinitis pigmentosa and Aldeyra’s plans and
expectations for ADX-2191. 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, requiring
additional clinical trials or data prior to review or approval 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; the
current and potential future impact of the COVID-19 pandemic on
Aldeyra’s business, results of operations, and financial position;
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,
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; 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, 2022, which is 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 1 Xi Y, Chen Y.
Pharmacological strategies for treating misfolded
rhodopsin-associated autosomal dominant retinitis pigmentosa.
Neural Regen Res. 2022 Jan;17(1):110-112. doi:
10.4103/1673-5374.314306. PMID: 34100444; PMCID: PMC8451548.
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Investors & Media Scott Solomon Sharon Merrill
Associates, Inc. Senior Vice President (857) 383-2409
ALDX@investorrelations.com
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