LEXINGTON, Mass., Oct. 10, 2017 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) ("Aldeyra" or "the
Company"), a clinical-stage biotechnology company devoted to
treating inflammation, inborn errors of metabolism, and other
diseases related to endogenous aldehyde toxicity, announced new
clinical data for ADX-102 from recently completed Phase 2 clinical
trials of dry eye disease and allergic conjunctivitis, and the
introduction of a retinal disease development program with ADX-103,
a novel aldehyde trap.
"These newly released results from our Phase 2 clinical trials
in dry eye disease and allergic conjunctivitis strongly support the
broad and clinically relevant activity profile of ADX-102 in ocular
inflammatory disease," commented Todd C.
Brady, M.D., Ph.D., President and Chief Executive Officer of
Aldeyra. "In addition, we are pleased to announce the expansion of
our ocular franchise with a new development program in retinal
disease, featuring our second novel aldehyde trap, ADX-103."
Dry Eye Disease Clinical Activity Correlated with Aldehyde
Reduction. Newly announced results from the recent Phase 2a
clinical trial in dry eye disease indicated that the statistically
significant reduction in levels of a pro-inflammatory aldehyde
mediator, malondialdehyde, was correlated with improvement of
ocular staining scores and tear osmolarity. To Aldeyra's knowledge,
these data represent the first correlation of drug biomarker
improvement with dry eye disease clinical activity. Aldeyra plans
to commence Phase 2b clinical testing of ADX-102 in dry eye disease
in the first half of 2018.
ADX-102 Generated Clinically Important Responses
Statistically Superior to Vehicle in Patients with Allergic
Conjunctivitis. Newly announced results from the recent Phase
2b clinical trial in allergic conjunctivitis indicated that 0.1%
and 0.5% ADX-102 groups were statistically superior to the vehicle
group in achieving a clinical response (p=0.02 for each group),
defined as within-patient one-point improvement in ocular itching
score (range 0 to 4) from peak baseline values. Odds ratio analysis
indicated that patients treated with each concentration of ADX-102
in the trial were greater than three times more likely to achieve a
clinical response than patients treated with vehicle. For the 0.1%
and 0.5% ADX-102 groups, time to within-patient one-point clinical
response was significantly faster than the vehicle group (p=0.0006
and p=0.008). In the United
States, ocular itching is an approvable endpoint for
allergic conjunctivitis, and one-point improvement represents the
regulatory precedent for clinical relevance. Allergic
conjunctivitis is a persistently disturbing and common ocular
disease affecting 20% or more of the worldwide population. Aldeyra
plans to commence Phase 3 clinical testing of ADX-102 in allergic
conjunctivitis in the first half of 2018.
Introduction of Retinal Disease Development Program with
Novel Aldehyde Trap ADX-103. ADX-103, a novel aldehyde
trap with a chemical structure distinct from ADX-102, demonstrated
activity in pre-clinical retinal disease models of macular
degeneration, uveitis, and diabetic macular edema. Retinal disease
represents one of the largest markets in ophthalmology and is
associated with the generation and accumulation of pro-inflammatory
and toxic aldehyde mediators. Additional results are expected to be
released at a major scientific meeting in 2018.
Webcast
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, 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.
About Dry Eye Disease
Dry eye disease is a
common inflammatory disease estimated to affect approximately 20
million people in the United
States, and is characterized by insufficient moisture and
lubrication in the anterior surface of the eye, leading to dryness,
inflammation, pain, discomfort, irritation, and in severe cases,
decreased vision. Among physicians and patients, existing therapy
for dry eye disease is generally regarded as inadequate. In
patients with dry eye disease, pro-inflammatory aldehyde mediators
may contribute to ocular inflammation. By diminishing aldehyde
levels, Aldeyra's topical ocular aldehyde trap platform represents
a novel and differentiated approach for the treatment of dry eye
disease.
About Allergic Conjunctivitis
Allergic
conjunctivitis is a common allergic disease that affects 20% or
more of the population worldwide. The disease is thought to be
mediated in part by pro-inflammatory aldehydes, and is
characterized by inflammation of the conjunctiva (a membrane
covering part of the front of the eye), resulting in ocular
itching, excessive tear production, lid swelling, and redness.
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 ADX-103; and the potential of ADX-102 as an agent for
the treatment of dry eye disease and allergic conjunctivitis and
ADX-103 as an agent for the treatment of retinal disease. 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: 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
Tel: 781-591-3443
cduong@macbiocom.com
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SOURCE Aldeyra Therapeutics, Inc.