Rapid and Durable Clinical Response
Demonstrated in Symptoms and Signs of Allergic Conjunctivitis
Clinical Relevance Demonstrated with Responder
Analyses
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that it will present new data from the Phase 2 allergen
chamber clinical trial of reproxalap ophthalmic solution (0.25% and
0.5%) in allergic conjunctivitis. The data will be presented in a
poster at the American Academy of Ophthalmology 2020 Virtual Annual
Meeting (AAO 2020) from November 11 through November 15, 2020.
In the randomized, double-masked, crossover, vehicle-controlled
Phase 2 clinical trial, 70 subjects with allergic conjunctivitis
were assessed over 3.5 hours in an allergen chamber of aerosolized
ragweed pollen (3,500 grains/m³). Reproxalap or vehicle ophthalmic
solution was administered bilaterally one minute before chamber
entry and at 90 minutes after chamber entry, when peak symptoms
typically occur. Compared to vehicle, both concentrations of
reproxalap demonstrated statistically significant and clinically
relevant improvements in subject-reported ocular itching and
tearing and investigator-assessed ocular redness over the duration
of exposure in the allergen chamber and for more than one hour
after exiting the chamber (P < 0.0001 for all assessments),
indicating both prophylactic and treatment effect of drug. In
addition, time-to-event responder analyses demonstrated the
clinical relevance of the superiority of reproxalap over vehicle
for ocular itching and ocular redness. No safety or tolerability
concerns were observed.
“The new data presented at AAO this year further support the
clinical utility of reproxalap, the first novel mechanistic
approach in late-stage allergic conjunctivitis clinical trials in
decades, as uniquely effective,” said Todd C. Brady, M.D., Ph.D.
President and CEO of Aldeyra. “The results of the allergen chamber
trial suggest that reproxalap could offer durable activity with an
onset of action that is essentially immediate.”
The 0.25% concentration of reproxalap was advanced to the Phase
3 INVIGORATE Trial, a randomized, double-masked, crossover,
vehicle-controlled clinical trial to assess the efficacy and safety
of reproxalap compared to vehicle using an allergen chamber.
Consistent with prior allergic conjunctivitis trials, the primary
endpoint will be subject-reported ocular itching score. Patient
enrollment is ongoing, and top-line results are expected in the
first half of 2021.
Details of the poster presentation:
Title:
A Phase 2 Clinical Trial of Topical Ocular
Reproxalap, a Novel RASP Inhibitor, in an Allergen Chamber Model of
Allergic Conjunctivitis
Session:
PO103 - Cornea, External Disease
Date/Time:
On Demand
Abstract Link:
https://bit.ly/2IU5egX
About Reproxalap
Reproxalap is a novel small-molecule immune-modulating covalent
inhibitor of reactive aldehyde species (RASP), which are elevated
in ocular and systemic inflammatory disease. Reproxalap’s mechanism
of action has been validated with the demonstration of
statistically significant and clinically relevant activity in
multiple physiologically distinct late-phase clinical
indications.
About Allergic Conjunctivitis
Allergic conjunctivitis affects more than 1 billion people
worldwide,1 including more than 66 million in the U.S.2 The disease
is thought to be mediated in part by reactive aldehyde species
(RASP), leading to activation of intracellular inflammatory
factors, including NF-κB, inflammasomes, and Scavenger Receptor A.
The symptoms of allergic conjunctivitis – ocular itching and
tearing – are chronic, painful, and persistent, affecting quality
of life and leading to loss of work that can create a substantial
economic burden for patients and their families.3 Although allergic
conjunctivitis is one of the most common diseases treated by
ophthalmologists and optometrists, in many cases physicians and
patients report that currently available therapy is inadequate.
Today, nearly one in five allergic conjunctivitis patients utilize
corticosteroids or other adjunctive therapy in addition to
antihistamines.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target
reactive aldehyde species (RASP), which are elevated in ocular and
systemic inflammatory disease and result in cytokine release via
activation of a broad array of inflammatory factors, including
NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being
evaluated in Phase 3 clinical trials in patients with dry eye
disease and allergic conjunctivitis. The company’s clinical
pipeline also includes ADX-2191, a dihydrofolate reductase
inhibitor in Phase 3 testing for proliferative vitreoretinopathy,
and ADX-1612, a chaperome inhibitor in development for COVID-19 and
ovarian cancer. 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 statements regarding Aldeyra's plans and expectations for
reproxalap ophthalmic solution as a potential treatment for
allergic conjunctivitis. 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,"
"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 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 review and quality
control analysis of clinical data, Aldeyra's ability to design
clinical trials with protocols 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; 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) 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 recent COVID-19 outbreak and subsequent public
health measures, 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, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, which are on file with the Securities
and Exchange Commission (SEC) and available on the SEC's website at
www.sec.gov. Additional factors may be described in those sections
of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2020, expected to be filed with the SEC in the fourth
quarter of 2020.
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 White Book on Allergy (2013
Update) 2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular
and nasal allergy in the United States, 1988-1994. J Allergy
ClinImmunol. 2010;126(4):778-783.e6 3 Andrew D. Pitt, Andrew F.
Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J.
Bron (2004) Economic and quality-of-life impact of seasonal
allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology,
11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437
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version on businesswire.com: https://www.businesswire.com/news/home/20201022005192/en/
Corporate: David McMullin Aldeyra Therapeutics, Inc. Tel:
781-761-4904 ext. 218 dmcmullin@aldeyra.com Investors &
Media: Scott Solomon Sharon Merrill Associates, Inc. Tel:
617-542-5300 ALDX@investorrelations.com
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