LEXINGTON, Mass., June 26, 2018 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology
company devoted to the development of next-generation medicines to
improve the lives of patients with immune-mediated diseases,
announced product development programs in systemic inflammatory
disease, retinal disease, and cancer at the company's 2018 Research
Day.
"Complementing our late-stage product candidate reproxalap, we
have continued to execute on our mission of expanding our pipeline
across multiple mechanisms of action and multiple molecular
compositions," commented Todd C.
Brady, M.D., Ph.D., President and Chief Executive Officer of
Aldeyra. "We are pleased to announce programs in immune-mediated
disease, including inflammatory bowel disease, non-alcoholic
steatohepatitis, retinal inflammation, lymphoproliferative immune
disease, and cancer."
Research Programs and Expected Milestones
- ADX-629 for the Treatment of Systemic Immune-Mediated
Disease
ADX-629 is an analog of reproxalap that diminished inflammatory
cytokine release in animal models, which has been linked to
multiple immune diseases such as non-alcoholic steatohepatitis
(NASH) and inflammatory bowel disease (IBD). Phase 1 clinical
testing of ADX-629 is expected to start in 2019.
- ADX-103 for the Treatment of Inflammatory Retinal
Disease
ADX-103 is a novel RASP (Reactive Aldehydes Species
that are Pro-inflammatory) inhibitor in development for the
treatment of inflammatory retinal disease such as potentially
diabetic macular edema, dry age-related macular degeneration, or
posterior uveitis. Phase 1/2 clinical testing of ADX-103 is
expected to start in 2019.
- ADX-1612 for Lymphoproliferative Immune Disease and
Cancer
ADX-1612 is a novel HSP90 inhibitor in development
for the treatment of post-transplant lymphoproliferative disorder
and cancer. Hsp90 is a protein that facilitates cell
replication, which is excessive and uncontrolled in certain
inflammatory diseases and cancer. ADX-1612 is currently being
studied in investigator-sponsored trials for mesothelioma, with
clinical results expected in the second half of 2018, and ovarian
cancer, with Phase 2 clinical trial initiation expected in the
second half of 2018. Aldeyra is further developing ADX-1612
for the treatment of lymphoproliferative immune disease, with Phase
2 clinical testing expected to start in 2019. The company is
also developing an oral pro-drug of ADX-1612, ADX-1615, for the
treatment of chronic immune-mediated disorders and cancer.
Presentation and Webcast
Management presentations
will begin at 9:00 a.m. Eastern Time on
Tuesday, June 26, 2018, at the offices of Dechert, LLP in
New York City. A live webcast of the presentation and slide
deck will be available on the investor relations page of Aldeyra's
corporate website at ir.aldeyra.com. After the live webcast, the
event will remain archived on Aldeyra's website for one year.
About Aldeyra Therapeutics
Aldeyra
Therapeutics is developing next-generation medicines to improve the
lives of patients with immune-mediated diseases. Aldeyra's lead
product candidate, reproxalap, is a first-in-class treatment in
late-stage development for dry eye disease and other forms of
ocular inflammation. The company is also developing other product
candidates for autoimmune and metabolic diseases. None of Aldeyra's
product candidates have 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
reproxalap and its other product candidates. 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, completion and reporting 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, 2017 and Aldeyra's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2018, both of which are on file with
the Securities and Exchange Commission(SEC) and available on
the SEC's website at www.sec.gov. 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, completion or reporting 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:
David McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
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SOURCE Aldeyra Therapeutics, Inc.