- Top-Line Results from First of Two Planned Clinical Trials
Based on Tear RASP Levels Expected by the End of 2020
- New Drug Application Submission for Reproxalap in Dry Eye
Disease Expected by the End of 2021
- Based on Current Operating Plans, Current Cash Expected to
Support Operations into 2022, Consistent with Prior Guidance
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), 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, today announced development plans to
support a New Drug Application (NDA) for the novel investigational
reactive aldehyde species (RASP) inhibitor reproxalap in dry eye
disease. Based on U.S. Food and Drug Administration (FDA) meeting
minutes, Aldeyra intends to initiate two clinical trials to assess
the activity of reproxalap in reducing tear levels of RASP,
pro-inflammatory mediators recently accepted by the FDA as an
objective sign of dry eye disease.
Top-line results from the first of the RASP trials are expected
by the end of 2020, pending potential disruptions due to the
COVID-19 pandemic. In addition, a safety trial in dry eye disease
patients is expected to be initiated in the fourth quarter of 2020.
NDA submission is expected in late 2021.
“Aldeyra’s written meeting minutes with the FDA confirming the
use of RASP as an objective sign for the treatment of dry eye
disease is a positive step in the regulatory science of novel
treatments for ocular surface disease,” stated Gary D. Novack,
Ph.D., Professor of Ophthalmology at the School of Medicine at
University of California, Davis, President of PharmaLogic
Development, Inc., and Chair of the Tear Film and Ocular Surface
Society DEWS (Dry Eye Workshop) II Clinical Trial Design Group.
“RASP assessment is a measurement of the mechanism of action of
reproxalap, and represents a potentially important biomarker-based
approach. This announcement comes in a context where we have few
biomarkers in pharmacotherapy for ocular diseases, and no
regulatory-based biomarkers in the treatment of ocular surface
disease.”
Assessment of RASP in the two planned trials is expected after
single and multiple doses of drug over two days. Investigational
new drug reproxalap covalently binds RASP via a series of reactions
that occur rapidly in vitro, and statistically reduced RASP levels
in the tears of dry eye patients in a Phase 2a clinical trial.
Aldeyra also reiterated financial guidance that, based on
current operating plans, cash, cash equivalents, and marketable
securities are sufficient to support operations into 2022,
including completion of the two planned RASP trials and the
company’s second Phase 3 clinical trial in allergic conjunctivitis,
the INVIGORATE Trial.
“With only one drug approved in the United States for the
treatment of the symptoms and signs of dry eye disease, the need
for therapeutic options with new mechanisms of action is
substantial,” stated Todd C. Brady, M.D., Ph.D., President and
Chief Executive Officer of Aldeyra. “Reproxalap is a first-in-class
investigational RASP inhibitor that, in the Phase 3 RENEW-1 Trial,
demonstrated potential rapid and broad symptom control we believe
is an important commercial differentiator.”
About RASP
RASP (reactive aldehyde species) are pre-cytokine
pro-inflammatory mediators that are elevated in the tears of
patients with dry eye disease,1 and correlate with dry eye disease
symptoms and signs.2 RASP covalently bind to cellular biomolecules,
altering molecular function and activating numerous
pro-inflammatory pathways implicated in human disease.
About Reproxalap
Reproxalap is a novel investigational small-molecule
immune-modulating covalent inhibitor of RASP in development as a
topically administered ophthalmic solution for dry eye disease and
allergic conjunctivitis. The mechanism of action of reproxalap has
been validated with the demonstration of statistically significant
and clinically relevant activity in multiple late-phase clinical
trials.
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, leading to elevated levels of
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 Phase 2
testing 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 strategy, future
operations, prospects, and development plans to support a New Drug
Application for reproxalap in dry eye disease and expectations
regarding FDA acceptance and review of such NDA and the sign and
symptom requirements. 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. As a
result of the COVID-19 pandemic, clinical site availability,
staffing, and patient recruitment have been negatively affected and
the timelines to complete our clinical trials may be delayed.
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
trials involving Aldeyra's product candidates; 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 our business, results of operations and
financial position; 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 March
31, 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 set forth in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
expected to be filed with the SEC in the third 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 Augustin et al., "Oxidative reactions in the tear fluid of
patients suffering from dry eyes," Graefe's Archive for Clinical
and Experimental Ophthalmology, 233(11):694-698 (1995).
2 Choi W., et al. Expression of Lipid Peroxidation Markers in
the Tear Film and Ocular Surface of Patients with Non-Sjogren
Syndrome: Potential Biomarkers for Dry Eye Disease. Curr Eye Res.
2016, 41(9):1143-9; Reproxalap preclinical and Phase 2a in dry eye
disease clinical trial results on file.
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version on businesswire.com: https://www.businesswire.com/news/home/20200707005260/en/
Corporate 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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