- Primary objective of RENEW Part 1 achieved:
Induction-maintenance dosing regimen of topical ocular reproxalap
advanced to RENEW Part 2
- Reproxalap statistically superior to vehicle in RENEW
co-primary endpoint of ocular dryness score in
induction-maintenance regimen - symptomatic improvement observed as
early as one week after initiation of therapy and at all measured
timepoints
- Relative to vehicle, induction-maintenance dosing regimen
demonstrated broad and statistically significant activity across
majority of assessed symptoms
- RENEW Part 2 expected to initiate in the first half of
2020
- Conference call to be held at 8:00 AM Eastern Standard Time
today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to developing and commercializing
next-generation medicines to improve the lives of patients with
immune-mediated diseases, announced today positive top-line results
from Part 1 of the adaptive Phase 3 RENEW Trial of topical ocular
reproxalap in patients with dry eye disease.
“To our knowledge, reproxalap is the first topical dry eye
disease drug to demonstrate statistically significant ocular
dryness symptom improvement relative to vehicle as soon as one week
after initiation of treatment, and thus has the potential to be
first-line therapy,” commented Todd C. Brady, M.D., Ph.D.,
President and Chief Executive Officer of Aldeyra. “The breadth of
symptomatic activity highlighted by the induction-maintenance
dosing regimen results in RENEW Part 1 demonstrate the potential of
reproxalap in treating dry eye disease, one of the largest - yet
least-served - markets in ophthalmology.”
The RENEW Trial is an ongoing adaptive, two-part, multi-center,
randomized, vehicle-controlled, double-masked, parallel-group Phase
3 trial of 0.25% topical ocular reproxalap compared to vehicle in
patients with moderate to severe dry eye disease. The primary
objective of RENEW Part 1 was to confirm dosing regimen, endpoints,
and sample size for RENEW Part 2. In Part 1 of RENEW, 422 patients
were randomized equally to receive either four-times-daily
reproxalap or vehicle for twelve weeks (the constant dosing group)
or four-times-daily reproxalap or vehicle for four weeks, followed
by twice-daily reproxalap or vehicle for eight weeks (the
induction-maintenance dosing group).
The primary objective of RENEW Part 1 was achieved. Observed
activity versus vehicle of the induction-maintenance dosing regimen
of topical ocular reproxalap was greater than that of the constant
dosing group, and the induction-maintenance dosing regimen will be
advanced to RENEW Part 2. The planned primary endpoints for RENEW
Part 2 are ocular dryness score and fluorescein nasal region ocular
staining score. RENEW Part 2 is expected to initiate in the first
half of 2020 and enroll approximately 400 patients per arm at
approximately 90% power to achieve statistical significance.
In the induction-maintenance dosing group, the RENEW co-primary
endpoint of patient-reported visual analog scale (VAS) ocular
dryness from Weeks 2 to 12 was achieved (p=0.0004), and activity
was observed as early as one week after initiation of therapy
(p=0.001) and was maintained until the end of the trial. In the
induction-maintenance dosing group from Weeks 2 to 12, reproxalap
was statistically superior to vehicle in VAS ocular endpoints for
itching (p=0.03), foreign body sensation (p=0.004), discomfort
(p=0.003), photophobia (p=0.004), and pain (p=0.03). In the
induction-maintenance dosing group from Weeks 2 to 12, reproxalap
was statistically superior to vehicle in Ocular Discomfort &
4-Symptom Questionnaire ocular endpoints for dryness (p=0.01),
discomfort (p=0.03), burning (p=0.03), grittiness (p=0.003), and
stinging (p=0.02). Although the improvement effect size of the
co-primary endpoint of fluorescein nasal region ocular staining did
not reach statistical significance, reproxalap was statistically
superior to vehicle in reduction from baseline in the
induction-maintenance dosing group from Weeks 1 to 4 of treatment
(p=0.03), and statistical separation from vehicle was observed at
Week 2 (p=0.04).
“The rapid amelioration of symptoms followed by symptomatic
control in the induction-maintenance dosing regimen supports the
potential of reproxalap to treat a wide range of dry eye disease
states, from severe flares to persistent symptoms,” stated Dr.
David Clark, Chief Medical Officer of Aldeyra. “In addition,
consistent with our positive Phase 3 results in allergic
conjunctivitis, reproxalap is one of the first dry eye disease
drugs to demonstrate activity in reducing ocular itching, a
prominent symptom associated with dry eye disease exacerbation,
which is especially common during allergy seasons.”
Consistent with clinical experience in over 1,100 patients, no
adverse findings on safety assessments were observed, and
reproxalap was well-tolerated. The most common reported adverse
event in reproxalap-treated patients was transient and mild
instillation site irritation. Less than 8% of reproxalap-treated
patients discontinued the trial due to adverse events, and moderate
ocular adverse events were reported in fewer than 1% of
subjects.
“Today’s dry eye disease population is underserved, and novel
therapies are in demand. Currently available therapies often
require weeks or months to demonstrate activity, and many patients
exhibit limited or no response, leading to between 50% to 80% of
patients dropping off therapy between their second and third
refill,” stated David McMullin, Chief Commercial Officer of
Aldeyra. “The early-onset and broad pattern of symptom improvement
in the induction-maintenance dosing regimen of reproxalap
demonstrated in RENEW Part 1 represents an attractive profile in
the dry eye disease market.”
Conference Call Aldeyra will host a conference call to
discuss this announcement today, December 3, 2019, at 8:00 a.m. ET.
The dial-in numbers are (866) 211-4098 for domestic callers and
(647) 689-6613 for international callers. The Conference ID is
1592481. A live webcast of the conference call will also be
available on the Investors Relations section of the Aldeyra
Therapeutics website at https://ir.aldeyra.com. Presentation slides
will be available on the investor relations page approximately 30
minutes prior to the start of the conference call and webcast.
After the live webcast, the event will remain archived on the
Aldeyra Therapeutics website for thirty days.
About Reproxalap Reproxalap is a novel, small-molecule
immune-modulating covalent inhibitor of reactive aldehyde species
(RASP), which are elevated in ocular and systemic inflammatory
disease. Reproxalap’s mechanism of action has been validated with
the demonstration of statistically significant and clinically
relevant activity in multiple physiologically distinct late-phase
clinical indications.
About Dry Eye Disease Dry eye disease is a common
inflammatory disease estimated to affect approximately 34 million
people in the United States. The disease is characterized by
insufficient moisture and lubrication in the anterior surface of
the eye, leading to dryness, inflammation, pain, discomfort,
irritation, diminished quality of life, and in severe cases,
permanent vision impairment. Among physicians and patients,
existing therapy for dry eye disease is generally regarded as
inadequate and often requires weeks or months to demonstrate
activity. In patients with dry eye disease, pro-inflammatory RASP
may contribute to ocular inflammation and changes in tear lipid
composition. By diminishing RASP levels, Aldeyra's RASP inhibitor
platform represents a novel and differentiated approach for the
treatment of the symptoms and signs of dry eye disease.
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,
proliferative vitreoretinopathy, and Sj�gren-Larsson Syndrome. 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 development plans and expectations for its
product candidates, including plans relating to current or future
clinical development of reproxalap in dry eye disease, the
potential of reproxalap to treat a wide range of dry eye disease
states and reduce ocular itching, and the potential to be
first-line therapy and first-in-class. 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,"
"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; 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
trials involving 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, 2018 and Aldeyra's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2019, which are 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191203005320/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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