- Highly statistically significant activity relative to vehicle
across every assessed symptom and sign observed in allergen chamber
clinical trial
- Agreement reached with U.S. FDA on design of Phase 3 INVIGORATE
trial, expected to initiate in the first half of 2020
- Company to host conference call and webcast at 8:00 a.m. ET
today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to developing and commercializing
next-generation medicines to improve the lives of patients with
immune-mediated diseases, today announced expanded results from the
company’s allergen chamber clinical methods trial (#NCT03709121) of
topical ocular reproxalap in patients with allergic conjunctivitis,
and Phase 3 clinical trial plans based on recent feedback from the
U.S. Food & Drug Administration (FDA).
“The expanded results from our allergen chamber trial
demonstrate highly statistically significant activity of reproxalap
relative to vehicle across all assessed symptoms and signs,"
commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
“Based on the positive outcome of the trial, we have reached
agreement with the FDA on the design and the primary endpoint for
our Phase 3 INVIGORATE trial – statistical significance in ocular
itching at a majority of time points over a pre-specified range.
Importantly, in the completed allergen chamber trial, all time
points to be pre-specified in the INVIGORATE trial were
statistically significant.”
The double-masked, randomized, vehicle-controlled, crossover
allergen chamber clinical methods trial assessed the efficacy and
safety of 0.25% and 0.5% concentrations of reproxalap topical
ophthalmic solution compared with vehicle in 70 patients with
ocular allergy to ragweed. Patient-reported ocular itching and
tearing, and investigator-assessed ocular redness, were recorded at
various intervals over approximately 3.5 hours during exposure to a
standardized amount of ragweed pollen. Test article was
administered before chamber entry and at 90 minutes post-entry,
near the peak of allergy symptoms and signs.
Relative to patients treated with vehicle, patients treated with
0.25% or 0.5% reproxalap demonstrated statistically significant
reduction in ocular itching (p<0.0001), redness (p<0.0001),
and tearing (p<0.0001). The total ocular symptom score, a
combination of itching, redness, and tearing, was also
significantly lower in reproxalap-treated subjects than in
vehicle-treated subjects (p<0.0001 for both concentrations).
Consistent with the positive results from the ALLEVIATE Phase 3
clinical trial in allergic conjunctivitis released earlier this
year, there was no statistical difference between the activity of
0.25% and 0.5% reproxalap. Consistent with all prior clinical
experience with topical ocular reproxalap in over 1,000 patients
across 12 clinical trials, there were no observed safety or
tolerability concerns, and the most common treatment-emergent
adverse event was transient instillation site irritation.
"We believe that the allergic conjunctivitis results released
today, in aggregate, represent the first rigorous demonstration of
activity of a late-stage, novel immune-modulating agent in an
allergen chamber," stated David J. Clark, M.D., M.R.C.P., Chief
Medical Officer of Aldeyra. "The allergen chamber is an innovative
and demanding assessment that combines real-world applicability
with controlled allergen exposure. The results from the trial
indicated distinct prophylactic and treatment activity of
reproxalap in reducing all of the primary signs and symptoms of
allergic conjunctivitis: ocular itching, redness, and tearing."
The Phase 3 INVIGORATE trial, which is expected to initiate in
the first half of 2020, will evaluate 0.25% reproxalap versus
vehicle in an allergen chamber. The primary endpoint will be
achieved if statistically significant reduction in ocular itching
between drug and vehicle is demonstrated at the majority of eleven
time points in a pre-specified range from 110 to 210 minutes
following chamber entry. In the completed allergen chamber trial,
reproxalap was statistically superior to vehicle at every time
point to be pre-specified in INVIGORATE.
Conference Call Aldeyra will host a conference call to
discuss this announcement today, October 31, 2019, at 8:00 a.m. ET.
The dial-in numbers are (866) 211-4098 for domestic callers and
(647) 689-6613 for international callers. The Conference ID is
4695959. A live, listen-only audio webcast of the conference call
can be accessed on the investor relations page of Aldeyra's
corporate website at ir.aldeyra.com. Presentation slides will be
available on the investor relations page approximately 30 minutes
prior to the start of the conference call and webcast.
After the live webcast, the event will remain archived on the
Aldeyra Therapeutics website for thirty days.
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
100 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-kB, 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 Allergic conjunctivitis is hyperendemic and prevalence
is increasing. 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
biotechnology company devoted to developing and commercializing
next-generation medicines to improve the lives of patients with
immune-mediated diseases. Aldeyra's lead investigational drug
product candidates are first-in-class potential treatments in
development for dry eye disease, allergic conjunctivitis,
proliferative vitreoretinopathy, and Sj�gren-Larsson Syndrome. The
company is also developing other product candidates for retinal and
systemic inflammatory diseases.
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 development plans and expectations for
reproxalap and strategy, future operations, future financial
position, projected costs and expenses, prospects, plans, and
objectives and Aldeyra's plans and expectations for its product
candidates, including plans relating to current or future clinical
development. 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," "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; the safety and efficacy results
of later phase or larger clinical trials confirming the results of
Aldeyra’s earlier trials; 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
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; 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, 2018 and
Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June
30, 2019, 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 set forth in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended September 30,
2019, expected to be filed with the SEC in the fourth quarter of
2019.
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/20191031005437/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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