- Positive Phase 3 Study Results Included in Dr. Eric Donnenfeld's Presentation
- Co-Primary Symptom Endpoint of Pain Met Statistical
Significance (P<0.025) and 7 of 11 Secondary Symptom Endpoints
Met Statistical Significance (P<0.05), 12-Week Treatment
Period
- Rapid Onset of Efficacy at the 2-Week Treatment
Period, Multiple Symptom Endpoints, Including the Co-Primary
Pain Endpoint, Met Statistical Significance and Continued to
Improve Over the 12-Week Treatment Period
- At the 2-Week Treatment Period, Multiple Sign Endpoints,
Including All 4 Fluorescein Staining Endpoints, Met
Statistical Significance (P<0.05)
- Excellent Safety and Tolerability Profile
- Discussions with FDA on Regulatory Approval Path Planned for
2Q 2024
CRANBURY, N.J., April 8,
2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE
American: PTN), a biopharmaceutical company developing
first-in-class medicines based on
molecules that modulate the activity
of the melanocortin receptor system, today
announced the presentation of topline results for its Phase 3
PL9643 MELODY-1 pivotal clinical trial evaluating the safety and
efficacy of PL9643 versus vehicle in the treatment of dry eye
disease (DED) at the American Society of Cataract and Refractive
Surgery (ASCRS).
The presentation by Dr. Eric
Donnenfeld, entitled "Updates, What's New in
Treatment, What's New and on the Threshold of FDA Approval"
was presented on Friday, April
5th, at the ASCRS Conference in Boston, Massachusetts. Dr. Donnenfeld's
presentation included MELODY-1 Phase 3 clinical data results, which
indicate that the Intent-to-Treat (ITT) PL9643 treatment population
demonstrated clinically meaningful and statistically significant
results at the change from baseline to week 12 for the co-primary
symptom endpoint of pain (p<0.025) and multiple exploratory
secondary symptom endpoints. The presentation also included an
overview of the excellent and superior safety and tolerability
profile of PL9643 compared to other approved treatments.
"Analysis of our successful Phase 3 MELODY-1 clinical trial
results, demonstrate that PL9643 has broad, robust and rapid
efficacy for multiple symptom endpoints. The efficacy results were
statistically significant for the co-primary symptom endpoint of
pain and 7 of 11 exploratory secondary endpoints, including eye
dryness, as early as two weeks (the 1st time point
measured). The effect improved and maintained statistical
significance over the 12-week treatment period," said Carl Spana, Ph.D., President and Chief Executive
Officer of Palatin. "Additionally, we have identified a substantial
patient population with statistically significant efficacy results
after two weeks of treatment with PL9643 for multiple sign
endpoints, including all four fluorescein staining endpoints, which
improves ocular surface disorders and facilitates the
identification and treatment of epithelial damage and corneal
injuries."
"The early onset of efficacy for multiple symptoms and signs of
dry eye disease and the excellent ocular safety and tolerability
profile positions PL9643 as a highly differentiated product. We are
advancing discussions with potential collaboration partners and
actively preparing for a meeting with the FDA later this quarter to
discuss the remaining studies for the PL9643 program required to
support an NDA submission," Dr. Spana continued.
"Dr. Donnenfeld's presentation is important, not only because it
illustrates PL9643 MELODY-1 positive results in the context of
other developmental programs for DED but identifies a potential key
differentiating treatment option for dry eye disease in terms of
its safety and tolerability profile," commented Michael Raizman, M.D., Chief Medical Officer at
Palatin.
Safety analysis from the Phase 3 MELODY-1 trial indicated PL9643
was well-tolerated. There were fewer ocular treatment related
adverse events in the PL9643 arm (5.6%, N=16/288) compared to
vehicle (6.3%, N=18/287), and fewer study discontinuations in the
PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%,
N=32/287). A higher proportion of the vehicle-treated patients
dropped out of the study prior to week 12 compared to the
PL9643-treated patients.
The Phase 3 MELODY-1 trial was a multi-center, randomized,
double–masked and vehicle–controlled study that enrolled 575
patients at sites in the U.S. The trial evaluated the safety and
efficacy of the melanocortin agonist, PL9643 ophthalmic solution
after treatment for 12 weeks, compared to vehicle in patients with
moderate-to-severe DED, for multiple sign and symptom endpoints.
The study design was based on positive Phase 2 results of PL9643
for the treatment of DED, and an end-of-Phase 2 meeting with the
FDA on key elements of the pivotal Phase 3 clinical program.
PL9643 represents an opportunity to bring relief to dry eye
sufferers. While DED is one of the most common ocular disorders,
affecting an estimated 38 million people in the U.S., only about 18
million are diagnosed and less than 10% of those diagnosed are
treated with a prescription product. This shows the significant
unmet medical need for an effective treatment that also has an
excellent safety and tolerability profile. 1 The
dry eye disease market size is estimated at $6.11 billion in 2024, and is expected to reach
$7.46 billion by 2029, growing at a
CAGR of 4.09% during the forecast period (2024-2029).
2
About the American Society of Cataract and Refractive Surgery
(ASCRS)
The ASCRS Annual Meeting, focused on therapeutic,
surgical, and administrative topics directly relevant to ASCRS and
ASOA members, offers symposia, lectures, workshops, sessions,
courses, and skills transfer labs to help anterior segment
surgeons, practice managers, administrators, technicians, and
nurses maintain and refine their skills.
About Dry Eye Disease (DED)
Dry eye disease is a
common inflammatory disease that, left untreated, can become
extremely painful and lead to permanent damage to the cornea and
vision. DED affects the cornea and conjunctiva of the eye resulting
in irritation, redness, pain, and blurred vision. 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. Existing therapy for DED
is generally regarded as inadequate by many physicians and
patients, and often requires months to demonstrate activity.
About Melanocortin Receptor Agonists and
Inflammation
The melanocortin receptor ("MCr") system has
effects on inflammation, immune system responses, metabolism, food
intake, and sexual function. There are five melanocortin receptors,
MCR1 through MCR5. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have medically significant pharmacological effects. Many tissues
and immune cells located in the eye (and other places, like the gut
and kidney) express melanocortin receptors, empowering our
opportunity to directly activate natural pathways to resolve
disease inflammation.
About Palatin
Palatin is a biopharmaceutical company
developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin receptor systems, with
targeted, receptor-specific product candidates for the treatment of
diseases with significant unmet medical need and commercial
potential. Palatin's strategy is to develop products and then form
marketing collaborations with industry leaders to maximize their
commercial potential. To learn more about Palatin, please visit us
on www.Palatin.com and follow us on Twitter at
@PalatinTech.
Forward-Looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin Technologies, Inc., such as
statements about Palatin products in development, including PL9643,
clinical trial results, potential actions by regulatory agencies
including the FDA, regulatory plans, development programs, proposed
indications for product candidates, and market potential for
product candidates
are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933,
Section 21E of the Securities Exchange Act of 1934 and as that term
is defined in the Private
Securities Litigation Reform Act of 1995. Palatin
intends that such forward-looking statements be
subject to the safe harbors created thereby. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that could cause Palatin's actual results to be materially
different from its historical results or from any results expressed
or implied by such forward-looking statements. Palatin's actual
results may differ materially from those discussed in the
forward-looking statements for reasons including, but not limited
to, results of clinical trials, regulatory
actions by the FDA and other regulatory agencies and the need for
regulatory approvals, Palatin's ability to fund development of its
technology and establish and successfully complete clinical trials,
the length of time and cost required to complete clinical trials
and submit applications for regulatory approvals, products
developed by competing pharmaceutical, biopharmaceutical and
biotechnology companies, commercial acceptance of Palatin's
products, and other factors
discussed in Palatin's periodic filings
with the Securities and Exchange Commission. Palatin
is not responsible for updating events that occur after the
date of this press release.
Palatin Technologies® is a registered trademark of
Palatin Technologies, Inc.
References
1. Market Scope 2023 Dry
Eye Product Market Review; does not include OTC artificial tears
and other Rx anti-inflammatory and tear stimulants.
2. Mordor Intelligence – Dry Eye Disease Market
Size & Share Analysis – Growth Trends & Forecasts
(2024-2029).
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SOURCE Palatin Technologies, Inc.