Top-Line Results Expected in February
CRANBURY, N.J., Feb. 5, 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 database lock for its PL9643 MELODY-1 pivotal Phase 3
clinical trial evaluating the safety and efficacy of PL9643 versus
vehicle in the treatment of dry eye disease (DED).
MELODY-1 has two co-primary efficacy endpoints: one clinical
sign of DED and one clinical symptom of DED. If one or both
co-primary end points are met, the study will be deemed a success
and the secondary end points will be evaluated using a hierarchical
testing strategy.
"We are excited by the database lock and that data analysis by
the independent statisticians has commenced. We look forward to
reporting top-line results from the PL9643 MELODY-1 pivotal Phase 3
clinical trial later in February," said Carl Spana, Ph.D., President and CEO of Palatin.
"I want to thank our clinical team, our study sites and our
independent service firms for their dedication and collaborative
efforts."
The pivotal Phase 3 MELODY-1 trial is 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, compared to vehicle in patients with moderate-to-severe
DED, for multiple sign and symptom endpoints, after treatment for
12 weeks. 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.
The remainder of the Phase 3 program, which includes the Phase 3
safety and efficacy study MELODY-2 and the open label MELODY-3
study are anticipated to commence patient enrollment in the second
half of calendar year 2024.
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. It is estimated
to affect over 20 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. Existing therapy for DED is generally regarded as
inadequate by many physicians and patients, and often requires
weeks or 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, for example 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, 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.
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SOURCE Palatin Technologies, Inc.