LEXINGTON, Mass., Oct. 24, 2017 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage
biotechnology company devoted to treating inflammation, inborn
errors of metabolism, and other diseases related to endogenous
aldehyde toxicity, presented novel data at the American Society of
Human Genetics 2017 Annual Meeting demonstrating that ADX-102
reduced levels of gamma-hydroxybutyrate (GHB) and
gamma-aminobutyrate (GABA) in a knockout mouse model of Succinic
Semialdehyde Dehydrogenase (SSADH) Deficiency.
SSADH Deficiency is an orphan neurological disease caused by
mutations in SSADH, resulting in elevated levels of succinic
semialdehyde. Excess succinic semialdehyde is converted into GHB,
GABA, and other metabolites that lead to severe neurological
dysfunction, including cognitive delay, seizures, and motor
dysfunction. Excess levels of GHB (also known as sodium oxybate, a
drug marketed for psychiatric disorders and used illicitly as an
intoxicant) and GABA impair neuronal transmission. A small number
of patients with a diagnosis of autism have been found to have
SSADH Deficiency.
"SSADH Deficiency is a debilitating orphan neurological disease
with no approved therapy," commented Todd
C. Brady, M.D., Ph.D., President and Chief Executive Officer
of Aldeyra. "The results presented last week suggest the potential
therapeutic applicability of aldehyde traps as a novel approach to
treating SSADH Deficiency by sequestering succinic semialdehyde and
other toxic aldehydes."
The data presented at the American Society of Human Genetics
2017 Annual Meeting showed analyses of GHB and GABA levels in the
brains of SSADH knockout mice. The results demonstrated that
ADX-102 diminished brain levels of GHB and GABA, and thus serve as
proof-of-concept for the utility of aldehyde sequestration as a
potential treatment for SSADH Deficiency.
About Succinic Semialdehyde Dehydrogenase
Deficiency
Succinic Semialdehyde Dehydrogenase (SSADH) Deficiency is a
neurological disease caused by genetic mutations that result in
elevated levels of succinic semialdehyde, which are toxic and
ultimately result in severe neurological dysfunction, including
motor dysfunction, seizures, speech impairment, intellectual
disability, and autistic behavior. There is currently no
FDA-approved therapy for SSADH Deficiency.
About Aldeyra Therapeutics
Aldeyra
Therapeutics, Inc. is a biotechnology company devoted to
improving lives by inventing, developing and commercializing
products that treat diseases thought to be related to endogenous
aldehydes, a naturally occurring class of pro-inflammatory and
toxic molecules. Aldeyra's lead product candidate, ADX-102,
is an aldehyde trap in development as topical eye drops for the
treatment of ocular inflammation. ADX-102 has now been tested in
over 250 patients in Phase 2 clinical trials in dry eye disease,
allergic conjunctivitis, and noninfectious anterior uveitis. A
dermatologic form of ADX-102 is in late-stage clinical development
for the treatment of ichthyosis due to Sjögren-Larsson Syndrome, an
inborn error of aldehyde metabolism. ADX-102 has not been approved
for sale in the U.S. or elsewhere.
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 plans and expectations for the
development of ADX-102 and the timing thereof; and the potential of
ADX-102 as an agent for the treatment of Succinic Semialdehyde
Dehydrogenase Deficiency (SSADHD). 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 "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. 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 ability to obtain and
maintain regulatory approval to conduct clinical trials and to
commercialize Aldeyra's product candidates, and the labeling for
any approved products; the scope, progress, expansion, and costs of
developing and commercializing Aldeyra's product candidates; the
size and growth of the potential markets for Aldeyra's product
candidates and the ability to serve those markets; Aldeyra's
expectations regarding Aldeyra's expenses and revenue, the
sufficiency 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 ability to
establish and maintain development partnerships; 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, 2016 and Quarterly Report on
Form 10-Q for the quarter ended June 30, 2017, 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 described in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, to be filed with the SEC in
the fourth quarter of 2017. 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.
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.
Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 ext. 205
stulipano@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com
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SOURCE Aldeyra Therapeutics, Inc.