- Statistically significant improvement from baseline observed in
investigator-assessed Eczema Area and Severity Index (EASI,
p=0.0006) and Investigator Global Assessment (IGA,
p<0.0001)
- EASI 75% improvement (EASI-75) threshold observed in three
patients (38%), and affected body surface area was completely
cleared in one patient (13%)
- Patient-reported itching eliminated in two patients (25%) and
clinically relevant threshold achieved in patient-reported eczema
score (POEM) in six patients (75%)
- Statistically significant improvement from baseline observed in
Hamilton Rating Scale for Depression (HAM-D, p=0.02)
- Results supportive of advancing ADX-246, an analog
investigational drug of ADX‑629, to Phase 1/2 placebo-controlled
clinical trial in healthy volunteers and atopic dermatitis
patients
- Company to present top-line results in conference call and
webcast 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 diseases,
today announced positive top-line results from a Phase 2 clinical
trial of ADX-629, an investigational RASP modulator, in patients
with atopic dermatitis. Relative to baseline, the clinical trial
demonstrated statistically significant and clinically relevant
improvement in investigator-assessed and patient-reported outcomes
across a number of different physiological and psychosocial
assessments, including complete resolution of affected body surface
area observed in one patient and elimination of itching reported by
two patients.
“The demand for safe, tolerable, and orally administered atopic
dermatitis therapies, particularly for mild to moderate patients,
is substantial,” stated Dr. Matthew Zirwas, founder of the Bexley
Dermatology Research clinic and Board-certified dermatologist who
served as Principal Investigator of the clinical trial. “The data
announced today offer a glimpse into what may be possible for many
patients who today are not adequately treated.”
An open-label, single-center Phase 2 clinical trial of ADX-629
was conducted in eight mild to moderate atopic dermatitis patients.
Over three months of treatment, patients received 250mg ADX-629,
administered orally twice daily. The primary endpoint of the
clinical trial was safety and tolerability. Secondary endpoints
included Eczema Area and Severity Index (EASI), Investigator Global
Assessment (IGA), Patient-Oriented Eczema Measure (POEM), Peak
Pruritus Numerical Rating Scale, time to flare, Hamilton Depression
Rating Scale (HAM-D), and Beck Anxiety Inventory (BAI).
Relative to baseline, over three months of treatment,
improvement was observed in all patients. Statistical significance
was achieved for improvement in EASI (p=0.0006). EASI thresholds
for 50% improvement (EASI‑50), 75% improvement (EASI-75), and 90%
improvement (EASI-90) were met in four patients (50%), three
patients (38%), and one patient (13%), respectively. Statistical
significance was achieved for improvement in affected body surface
area (p<0.0001); one patient (13%) achieved complete clearance
of affected body surface area. Statistical significance was
achieved for improvement in IGA (p<0.0001). The IGA threshold
score of 0 (clear) or 1 (almost clear) was met in one (13%)
patient. Statistical significance was achieved for improvement in
patient-reported itching (p=0.0002); the clinically relevant
threshold of improvement by 4 or more points was met in three
patients (38%), and two patients (25%) reported elimination of
itching. Statistical significance was achieved for improvement in
patient-reported eczema severity (POEM, p<0.0001); the
clinically relevant threshold of improvement by 4 or more points
was met in six patients (75%). Statistical significance was
achieved for improvement in depression (HAM-D, p=0.02) and
numerical improvement was observed for improvement in anxiety (BAI,
p=0.1).
All enrolled patients completed the trial per protocol. No
patients experienced flare requiring rescue therapy. Only two
adverse events deemed to be at least possibly related to ADX-629
were reported, and both events were mild. There were no observed
serious adverse events or discontinuations due to adverse
events.
“The results from the clinical trial of ADX‑629 in atopic
dermatitis are consistent with activity demonstrated in previously
disclosed clinical trials of ADX‑629, including Phase 2 clinical
trials in psoriasis, asthma, and chronic cough, adding to a growing
body of evidence that we believe is supportive of the activity of
RASP modulators in systemic diseases associated with inflammation,”
stated Todd C. Brady, M.D., Ph.D., President and Chief Executive
Officer of Aldeyra. “Based on the signal-finding activity of
ADX‑629, we enthusiastically plan to advance our next-generation
investigational RASP modulator ADX‑246 to Phase 1/2 clinical
testing in healthy volunteers and patients with atopic
dermatitis.”
Aldeyra expects to initiate a multicenter, randomized,
placebo-controlled Phase 1/2 clinical trial of ADX‑246 in healthy
volunteers and patients with atopic dermatitis in the first half of
2024. Topline results from the trial are expected in the second
half of 2024.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today,
December 19, 2023, to discuss the top-line results of the Phase 2
clinical trial of ADX-629 in atopic dermatitis. The dial-in numbers
are (888) 415-4305 for domestic callers and (646) 960-0336 for
international callers. The access code is 5858366. A live audio
webcast of the conference call also will be accessible from the
“Investors & Media” section of Aldeyra's website at
ir.aldeyra.com. A live webcast of the conference call will be
available on the Investor Relations page of the company’s website
at https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the Aldeyra Therapeutics website for 90
days.
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 and
allergic conjunctivitis, and ADX-2191, a novel formulation of
intravitreal methotrexate for the potential treatment of
proliferative vitreoretinopathy and retinitis pigmentosa.
About ADX-629 and ADX-246
ADX-629 is an orally administered RASP modulator currently in
development as a signal-finding molecule for the treatment of
mass-market immune-mediated diseases. ADX‑629 has demonstrated
potential activity in clinical trials of patients with psoriasis,
asthma, COVID, ethanol toxicity, chronic cough, and atopic
dermatitis. In more than 100 healthy volunteers and patients, no
consistent adverse events associated with ADX‑629 have been
identified. An analog of ADX-629, ADX‑246 is an orally administered
next-generation RASP modulator expected to initiate clinical
testing in the first half of 2024 in a Phase 1/2 clinical trial in
healthy volunteers and patients with atopic dermatitis. Top-line
results from the Phase 1/2 clinical trial are expected in the
second half of 2024.
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 ADX-629 and ADX-246, and anticipated clinical or
regulatory milestones for ADX-629 and ADX-246. 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, or 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;
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, 2022, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023, 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, 2023, expected
to be filed with the SEC in the first 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/20231219830494/en/
Investor & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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