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 positive top-line
Phase 1 clinical trial results for ADX-629, a first-in-class orally
available reactive aldehyde species (RASP) inhibitor in development
for the treatment of systemic immune-mediated diseases. Aldeyra
also announced Phase 2 clinical development plans for ADX-629.
The Phase 1 clinical trial was a single-ascending and
multiple-ascending dose trial to assess the pharmacokinetic,
pharmacodynamic, safety, and tolerability profile of ADX-629
administered orally to healthy volunteers. Of the 85 subjects
enrolled in the trial, 41 received ADX-629 orally as a single dose;
23 received ADX-629 orally twice per day for 10 days; and 21
received placebo. ADX-629 was well-tolerated, and no
treatment-related adverse events were observed in the trial. No
clinically meaningful changes were observed in vital signs,
quantitative electrocardiography, or blood chemistry results.
Clinically relevant plasma concentrations exceeding known levels of
RASP were observed. Relative to subjects treated with placebo,
reduction in the commonly described pro-inflammatory RASP
malondialdehyde was observed in treated subjects.
“To our knowledge, ADX-629 is the first orally available and
irreversible covalent inhibitor of pro-inflammatory RASP, and
potentially represents a new paradigm in the understanding and
treatment of immune-mediated disease,” stated Todd C. Brady, M.D.,
Ph.D., President and CEO of Aldeyra. “The results from the Phase 1
clinical trial announced today support the potential to test
ADX-629 broadly across serious diseases characterized by severe
inflammation not well-addressed by current therapy.”
Unlike most currently available drugs, the RASP targets of
ADX-629 are small molecules rather than proteins. As such, ADX-629
could represent a new pharmacotherapeutic approach with potential
applications across a large number of immune-mediated diseases.
RASP are upstream mediators of inflammation, regulating known
mediators such as NF-κB, inflammasomes, and scavenger receptor A.
ADX-629 covalently binds RASP, which are then degraded
intracellularly. In animal models of cytokine storm, ADX-629 and
structural analog reproxalap, now in Phase 3 clinical testing for
certain inflammatory ocular diseases, have demonstrated reduction
in the levels of a variety of pro-inflammatory cytokines, including
TNF-α, IFN-γ, IL-1, and IL-17, while upregulating the principal
anti-inflammatory cytokine, IL-10.
Aldeyra plans to facilitate the clinical testing of ADX-629 in
patients with COVID-19-associated respiratory compromise by
requesting a pre-investigational new drug meeting with the
Infectious Disease Division of the U.S. Food and Drug
Administration (FDA). In addition, Aldeyra has filed ADX-629 under
the FDA’s Coronavirus Treatment Acceleration Program (CTAP). By
potentially mitigating aberrant cytokine responses, ADX-629 may
delay or prevent progression of acute respiratory distress syndrome
and other forms of respiratory compromise that generally require
mechanical ventilation.
In addition, contingent on clinical research facility
availability, which is currently limited due to COVID-19
precautions, Aldeyra plans to test ADX-629 in Phase 2 clinical
trials of respiratory and dermal conditions associated with
elevated levels of RASP, potentially including atopic asthma,
chronic cough, psoriasis, and atopic dermatitis.
“We are excited to add potential new milestones to our clinical
pipeline as we advance ADX-629 to Phase 2 clinical testing and
expand our clinical development focus to include systemic disease,”
Dr. Brady stated.
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 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.
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, plans, and objectives and Aldeyra's plans
and expectations for its product candidates, including expectations
regarding the potential of its RASP inhibitors, including ADX-629
and reproxalap, for potential anti-inflammatory and antiviral
activity in the treatment of COVID-19. 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, which is 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 March 31, 2020,
expected to be filed with the SEC in the second 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200414005199/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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