- Statistical Significance Achieved for Primary Endpoint of
Ocular Itching at All Prespecified Timepoints
(P<0.0001)
- Statistical Significance Achieved for Key Secondary Endpoint
of Ocular Redness (P=0.004)
- Statistical Significance Achieved for Secondary Endpoints of
Ocular Tearing (P<0.0001) and Total Ocular Severity Score
(P<0.0001)
- Results Consistent with Previous Phase 2 and Phase 3
Clinical Trials in Allergic Conjunctivitis
- Activity in Allergic Conjunctivitis Complements Commercial
Potential in Dry Eye Disease
- Company to Discuss 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 the Phase 3
INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution
(reproxalap), an investigational new drug, in patients with
allergic conjunctivitis. The clinical trial successfully achieved
statistical significance for the primary endpoint and all secondary
endpoints.
“Consistent with the results of the Phase 3 INVIGORATE Trial and
in conjunction with a number of successful Phase 2 and Phase 3
clinical trials in dry eye disease, achievement of the primary
endpoint and all secondary endpoints in INVIGORATE-2 supports the
potential of reproxalap as a treatment for inflammatory diseases of
the ocular surface,” stated Todd C. Brady, M.D., Ph.D., President
and CEO of Aldeyra. “We believe that the rapid-onset activity of
reproxalap evidenced in the INVIGORATE clinical trials may offer
hope to allergic conjunctivitis patients who are today not
adequately treated, and also to dry eye disease patients, up to 50%
of whom suffer from ocular allergy.”
The randomized, double-masked, vehicle-controlled, two-way
crossover design allergen chamber Phase 3 INVIGORATE‑2 Trial
enrolled 131 allergic conjunctivitis patients. The primary efficacy
endpoint was change from baseline in patient-reported ocular
itching score on a 0‑4 point scale over a majority of 11 timepoints
from 110 to 210 minutes after allergen chamber entry. The key
secondary endpoint was change from baseline in ocular redness on a
0‑4 point scale over the duration of the allergen chamber
(approximately 3.5 hours).
Relative to patients treated with vehicle, patients treated with
reproxalap reported statistically significant ocular itching score
reduction across all 11 prespecified primary endpoint comparisons
(P<0.0001 for each comparison) from 110 to 210 minutes in the
allergen chamber. The reproxalap-treated patients demonstrated
statistically significant reduction from baseline compared to
vehicle (P=0.004) for the key secondary endpoint of
investigator-assessed ocular redness over the duration of the
allergen chamber. Statistical significance was also achieved for
the two secondary endpoints of change from baseline in
patient-reported ocular tearing score on a 0‑3 point scale over the
duration of the allergen chamber (P<0.0001) and change from
baseline in total ocular severity score (11‑point composite of the
itching, redness, and tearing scores) over the duration of the
allergen chamber (P<0.0001).
“The co-morbidity of allergic conjunctivitis and dry eye disease
poses diagnostic and treatment challenges to patients and
healthcare providers,” stated William B. Trattler, MD., Vice Chair
of Research and Associate Professor of Ophthalmology at Herbert
Wertheim College of Medicine. “For patients who have had a poor
response to over-the-counter ocular allergy medications, the data
announced today may suggest that reproxalap could satisfy a
substantial unmet need in patients who suffer from allergic
conjunctivitis and dry eye disease.”
Reproxalap ophthalmic solution has now been administered to more
than 2,400 patients across 21 clinical trials. Consistent with
prior clinical experience with reproxalap, there were no observed
safety or tolerability concerns in the INVIGORATE-2 Trial; the most
common adverse event was mild and transient instillation site
irritation. No patients discontinued due to adverse events, and 130
of 131 randomized patients completed the clinical trial. A New Drug
Application (NDA) of reproxalap for the treatment of dry eye
disease is under review at the U.S. Food and Drug Administration.
The NDA Prescription Drug User Fee Act (PDUFA) date for reproxalap
for the treatment of dry eye disease is November 23, 2023.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to
discuss results of the INVIGORATE-2 Trial. The dial-in numbers are
(833) 470-1428 for domestic callers and (404) 975-4839 for
international callers. The access code is 349573. 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. Due to the expected high demand on our conference
provider, please plan to dial in to the call at least 15 minutes
prior to the start time.
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 Reproxalap
Reproxalap, an investigational new drug candidate, is a
first-in-class small-molecule modulator of RASP (reactive aldehyde
species), which are elevated in ocular and systemic inflammatory
disease. The mechanism of action of reproxalap has been supported
by the demonstration of statistically significant and clinically
relevant activity in multiple physiologically distinct late-phase
clinical indications. Reproxalap has been studied in more than
2,400 patients with no observed safety concerns; mild and transient
instillation site irritation is the most commonly reported adverse
event in clinical trials.
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 Priority 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 likelihood
and timing of the FDA’s potential approval of the NDA for
reproxalap by the PDUFA date, or at any other time, and the
adequacy of the data included in the NDA submission, and the
commercial potential of reproxalap. 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, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 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 Quarterly Report on
Form 10-Q for the quarter ended June 30, 2023, expected to be filed
with the SEC in the third 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230615100812/en/
Investor & Media Contact:
David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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