Previously Announced Phase 2 Clinical Trials
Initiated in Minimal Change Disease and Sj�gren‑Larsson
Syndrome
Phase 2 Clinical Trial in Minimal Change
Disease Expanded to Encompass Idiopathic Nephrotic Syndrome, a
Broad Group of Rare Kidney Disorders
New Phase 2 Clinical Trial Initiated in
Atopic Dermatitis
Previously Announced Credit Facility
Amendment Extends Cash Runway into the Second Half of 2024
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced the initiation of Phase 2 clinical trials evaluating the
safety and efficacy of ADX‑629, a novel, internally developed,
investigational oral RASP modulator, for the treatment of minimal
change disease and Sj�gren-Larsson Syndrome. Aldeyra also announced
the expansion of the minimal change disease clinical trial to
encompass idiopathic nephrotic syndrome, a broad group of rare
immune-mediated kidney disorders that includes minimal change
disease. Additionally, Aldeyra announced the initiation of a Phase
2 clinical trial of ADX‑629 in atopic dermatitis.
“Following the completion of successful proof-of-concept trials
in psoriasis, asthma, COVID-19, and alcohol toxicity, the ADX‑629
trials announced today further advance the promising novel
pharmacology of our proprietary RASP modulator platform for the
treatment of systemic diseases,” said Todd C. Brady, M.D., Ph.D.,
President and Chief Executive Officer of Aldeyra. “ADX-629 has the
potential to become a first-in-class therapy that may allow for
convenient, non-injected, orally administered, broad-based
treatment of immune-mediated diseases.
“With the recently amended credit facility, we believe that our
cash runway is extended into the second half of 2024 and that we
are well positioned to advance our novel investigational product
candidates for systemic diseases while executing on initial
commercialization activities for reproxalap and ADX-2191, if
approved,” Dr. Brady stated.
Disease Targets
- Idiopathic Nephrotic Syndrome: Idiopathic nephrotic
syndrome is comprised of a broad group of renal inflammatory
diseases, including minimal change disease, and is characterized by
edema, proteinuria, and hypoalbuminemia. The adaptive, multicenter,
two‑part Phase 2 clinical trial will evaluate the safety and
efficacy of ADX‑629 and placebo over 12 weeks of treatment in
children and adults. Part 1 is expected to enroll five patients who
will be treated with ADX‑629. Pending the results of Part 1, Part 2
will compare ADX‑629 to placebo. Outcomes will include frequency of
relapse, as defined by requirement for corticosteroid therapy.
Top-line results from Part 1 of the clinical trial are expected in
2023.
- Sj�gren-Larsson Syndrome: Sj�gren-Larsson Syndrome is an
autosomal recessive neurocutaneous inborn error of metabolism that
prevents degradation of specific RASP, and most commonly affects
children and adolescents. The investigator-sponsored, open-label,
Phase 1/2 clinical trial will evaluate the safety,
pharmacodynamics, and exploratory clinical activity in up to 10
patients over 12 weeks of treatment. Outcomes will include plasma
and imaging markers of metabolism and brain activity, quality of
life, neurological function, and skin assessments. Top-line results
are expected in 2023.
- Atopic Dermatitis: Atopic dermatitis is a chronic
hypersensitivity condition that is characterized by dry, itchy, and
inflamed skin, and commonly affects children and adults. The
adaptive, multicenter, two-part Phase 2 clinical trial will
evaluate the safety and efficacy of ADX‑629 over 12 weeks of
treatment. Part 1 of the trial is expected to enroll approximately
10 patients. Pending the results of Part 1, Part 2 will compare
ADX-629 to placebo. Outcomes will include improvement in
Investigator Global Assessment and Eczema Area and Severity Index
scores. Top-line results from Part 1 of the clinical trial are
expected in 2023.
In addition to the trials in idiopathic nephrotic syndrome,
Sj�gren-Larsson Syndrome, and atopic dermatitis, the ADX-629
program includes the following clinical development
initiatives:
- Chronic Cough: ADX-629 is currently being
evaluated in a multicenter, randomized, double-blind,
placebo-controlled, two-period Phase 2 crossover trial in
approximately 50 patients with refractory or unexplained chronic
cough. Top-line results are expected in the first half of
2023.
- Moderate Alcohol-Associated Hepatitis: Aldeyra
plans to support an investigator-sponsored Phase 2 clinical trial
of ADX‑629 in moderate alcohol-associated hepatitis. The trial is
expected to be initiated in 2023. In a Phase 2 clinical trial
announced last year, ADX-629 reduced dermal flushing and improved
balance time following alcohol intoxication.
About ADX‑629
ADX‑629 is a novel, orally administered investigational RASP
modulator for the potential treatment of systemic and retinal
immune-mediated diseases. RASP modulators potentially represent
upstream immunological switches that shift immune systems from
pro-inflammatory states to anti-inflammatory states. ADX-629 is a
member of the same chemical class as reproxalap, an investigational
new drug under New Drug Application review for the treatment of dry
eye disease, a common ocular inflammatory disease.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company
developing innovative therapies designed to treat immune-mediated
diseases. Our approach is to discover 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 pre-commercial
product candidates are reproxalap, a potential treatment for dry
eye disease and allergic conjunctivitis, and ADX-2191, a potential
treatment for primary vitreoretinal lymphoma, proliferative
vitreoretinopathy, and retinitis pigmentosa. In addition, we are
developing other product candidates, including ADX-629 and
chemically related molecules, for the potential treatment of
systemic and retinal immune-mediated 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 top-line
results from the clinical trials of ADX-629 in idiopathic nephrotic
syndrome, Sj�gren-Larsson Syndrome, atopic dermatitis, and chronic
cough; the planned initiation of the investigator-sponsored Phase 2
clinical trial of ADX-629 in moderate alcohol-associated hepatitis;
the Company’s plans to execute on its initial commercialization and
launch plans for reproxalap and ADX-2191; the Company’s plans for
continued development of its novel investigational product
candidates for systemic diseases; and the Company’s operating plans
and expectations regarding the sufficiency and uses of its existing
cash, cash equivalents and marketable securities. 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.
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Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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