Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that it will begin screening its library of novel
reactive aldehyde species (RASP) inhibitors, including ADX-629 and
reproxalap, for potential anti-inflammatory and antiviral activity
in the treatment of COVID-19 infection.
ADX-629 and reproxalap are structurally related to chloroquine
and hydroxychloroquine, drugs currently in clinical testing for the
treatment of COVID-19 infection.
“We are committing scientific expertise and development
resources associated with our RASP platform to help reduce the
impact of the COVID-19 global healthcare crisis,” stated Todd C.
Brady, M.D., Ph.D., President and CEO of Aldeyra. “Given the strong
association between RASP and acute respiratory distress syndrome
(ARDS), as well as the structural similarity of reproxalap and
ADX-629 to chloroquines, we are researching the potential of our
novel RASP inhibitors to mitigate the clinical severity of COVID-19
infection.”
Reproxalap1 and ADX-6292 have been shown to diminish
inflammation in animal models of cytokine storm. Reproxalap has
also demonstrated preliminary activity in a preclinical model of
ARDS3.
Aldeyra also announced that, in response to a recent U.S.
Department of Health and Human Services solicitation, Aldeyra has
submitted a proposal to the Biomedical Advanced Research and
Development Authority (BARDA) for the development of ADX-629 for
the treatment of COVID-19 infection. ADX-629 has completed a single
and multiple ascending dose Phase 1 clinical trial. Initiation of a
Phase 2 clinical trial of ADX-629 in patients with immune-mediated
disease is planned for the second half of 2020.
Aldeyra is also seeking healthcare industry partners that may be
interested in testing ADX-629 pursuant to the U.S. Food and Drug
Administration’s Emergency Use Authorization guidelines. Physicians
wishing to use ADX-629 under a single patient Investigational New
Drug (IND) application for Compassionate or Emergency Use should
email Dr. James Gow, Senior Vice President of Clinical Development,
at james.gow@aldeyra.com.
“We believe that ADX-629 could potentially be an important tool
for physicians treating patients who are experiencing ARDS
associated with COVID-19, either as a single agent or as an adjunct
to other therapies,” Dr. Brady stated.
About ADX-629
ADX-629 is an orally administered RASP inhibitor with potential
antiviral and anti-inflammatory activity. The compound has
completed a single-ascending and multiple-ascending dose Phase 1
clinical trial in 85 subjects with no drug-related adverse events
observed. ADX-629 is a member of the same chemical class as
reproxalap, a RASP inhibitor in Phase 3 clinical testing for ocular
inflammation.
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, and lead to activation
of intracellular inflammatory factors, including NF-kB,
inflammasomes, and Scavenger Receptor A. The mechanism of action of
reproxalap has been validated with the demonstration of
statistically significant and clinically relevant activity in
multiple physiologically distinct late-phase clinical
indications.
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 potential
first-in-class treatments in development for dry eye disease,
allergic conjunctivitis, and proliferative vitreoretinopathy. 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 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.
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 Cullen V, Mechanic J, Welihinda A, Young S, Amento E, Brady T.
The small molecule aldehyde trap NS2 exhibits potent
anti-inflammatory activity in 3 murine models of inflammation.
Poster session presented at: American Academy of Allergy Asthma
& Immunology 2015 Annual Meeting; 2015 Feb 20-24; Houston, TX.
2 Data on file. 3 Macdonald SG, Cullen V, Brady T, Beal D,
Andreotta PW, Young SL. The Novel Aldehyde Trap, ADX-102, Reduces
Inflammation-Mediated Lung Infiltrate in a Mouse Model of
LPS-Induced Acute Lung Injury. Poster session presented at: World
Congress on Inflammation 2017 Meeting; 2017 Jul 8-12; London,
United Kingdom.
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version on businesswire.com: https://www.businesswire.com/news/home/20200324005325/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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