- Statistical Significance of Reproxalap Over Vehicle Achieved
for Ocular Redness, an FDA-Approvable Sign, and Clinical Symptoms
of Ocular Dryness and Discomfort
- Acute Improvement in Ocular Redness and Symptom Scores
Demonstrated Within Minutes of Reproxalap Administration in Dry Eye
Chamber
- Main Cohort of TRANQUILITY Expected to Begin Enrollment in
February 2021, Following Completion of Tear RASP Analysis and
Finalization of Trial Design
- Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced positive top-line symptom, redness, and Schirmer’s test
results from the run-in cohort of the Phase 3 TRANQUILITY clinical
trial in patients with dry eye disease.
The double-masked, single-center, parallel-group run-in cohort
enrolled 23 patients: 12 patients were randomized to receive 0.25%
reproxalap ophthalmic solution and 11 patients were randomized to
receive vehicle ophthalmic solution. Patients received four doses
one day prior to and two doses on the day of exposure to a
90-minute dry eye chamber with minimal humidity, high airflow, and
forced visual tasking.
Over all time points in aggregate in the dry eye chamber,
reproxalap was observed to be statistically superior to vehicle for
the two assessed symptoms, visual analog scale (VAS) ocular dryness
score (p = 0.001) and ocular discomfort score (p < 0.0001) in
the run-in cohort of TRANQUILITY. Consistent with previously
announced allergen chamber Phase 2 clinical trial results,
reproxalap demonstrated statistically significant improvement over
vehicle (p = 0.03) in ocular redness, an objective sign of dry eye
disease. Improvement in ocular symptoms and redness occurred within
minutes after reproxalap dosing. Following acute dosing on the day
prior to the dry eye chamber, Schirmer test scores were
directionally in favor of reproxalap over vehicle, and reproxalap
was statistically superior to vehicle in improvement in VAS dryness
score (p = 0.003), ocular discomfort 4-symptom questionnaire
(OD4SQ) dryness score (p = 0.006), OD4SQ grittiness score (p =
0.006), and OD4SQ discomfort score (p = 0.003). Consistent with
clinical experience in over 1,100 patients, no adverse findings on
safety assessments were observed, and reproxalap was
well-tolerated.
“The symptom improvement observed in the run-in cohort of
TRANQUILITY announced today support the first-line potential use of
reproxalap in dry eye disease, and represent the first results from
an ophthalmic solution for chronic use that demonstrate activity
acutely following drug administration,” stated Todd C. Brady, M.D.,
Ph.D., President and Chief Executive Officer of Aldeyra. “The
activity of reproxalap in reducing ocular redness, initially
demonstrated in the allergen chamber Phase 2 clinical trial, was
also observed in the dry eye chamber run-in results of TRANQUILITY,
and we look forward to initiating enrollment of the main
cohort.”
Among many patients and physicians, current dry eye disease
therapies are considered inadequate. Discontinuation rates for
lifitegrast and cyclosporine, which currently comprise standard of
care, exceed 60% within 12 months of initiation of therapy, in part
due to delayed onset of effect.1
“The potential for patients to experience acute symptomatic
relief and observe rapid improvement in ocular redness after the
initiation of therapy represents a new possible paradigm in dry eye
disease treatment and could offer significant clinical advantage
over existing therapies, which often require weeks of drug
administration before patients experience even moderate
improvement,” stated Victor Perez, M.D., Professor of Ophthalmology
at Duke University School of Medicine and a member of Aldeyra’s
Anterior Segment Scientific Advisory Board.
The main cohort of TRANQUILITY is expected to begin enrollment
in February 2021, following completion of tear RASP analysis from
the run-in cohort and confirmation of endpoints and number of
subjects. Results from TRANQUILITY are expected in the second half
of 2021. A second Phase 3 clinical trial, TRANQUILITY-2, is
expected to initiate in the first quarter of 2021.
Conference Call Information
Aldeyra will host a conference call to discuss this announcement
today, Thursday, January 7, 2021, 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 7076648. A live
webcast of the conference call will also be available on the
Investor Relations section of the Aldeyra Therapeutics website at
https://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 90 days.
About Reproxalap
Reproxalap is a novel small-molecule immune-modulating covalent
inhibitor of RASP (reactive aldehyde species), 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.
Reproxalap is currently in Phase 3 clinical development as a 0.25%
ophthalmic solution for the treatment of dry eye disease and
allergic conjunctivitis, two ocular inflammatory diseases that
often occur together in the same patient.
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to
affect 34 million or more adults in the United States.2 The disease
is characterized by insufficient moisture and lubrication in the
anterior surface of the eye, leading to dryness, inflammation,
pain, discomfort, irritation, diminished quality of life, and in
severe cases, permanent vision impairment. Among many physicians
and patients, existing therapy for dry eye disease is generally
regarded as inadequate and often requires weeks or months to
demonstrate activity. In patients with dry eye disease,
pro-inflammatory RASP may contribute to ocular inflammation and
changes in tear lipid composition. By diminishing RASP levels,
Aldeyra’s lead RASP inhibitor reproxalap represents a novel and
differentiated approach for the treatment of the symptoms and signs
of dry eye disease.
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 investigational compounds, reproxalap and
ADX-629, target RASP (reactive aldehyde species), 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 the initial clinical results from
the run-in cohort of the Phase 3 TRANQUILITY Trial and expectations
regarding the main cohort of TRANQUILITY and the TRANQUILITY-2
Trial. 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 risk
that the results from smaller clinical trials or portions of
clinical trials may not accurately predict results of larger scale
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) 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
September 30, 2020, 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, 2020, expected to be filed with the SEC in the first
quarter of 2021.
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 DE, Zhao Y, Ogundele A, et al. Real-World Treatment
Patterns of Cyclosporine Ophthalmic Emulsion and Lifitegrast
Ophthalmic Solution Among Patients with Dry Eye. Clin Ophthalmol.
2019;13:2285-2292.
2 Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the
beaver dam offspring study: prevalence, risk factors, and
health-related quality of life. Am J Ophthalmol.
2014;157(4):799-806. doi:10.1016/j.ajo.2013.12.023.
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version on businesswire.com: https://www.businesswire.com/news/home/20210107005235/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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