CRANBURY, N.J., Dec. 28, 2021 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a specialized
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin peptide
receptor system, announced the initiation of the pivotal Phase 3
MELODY-1 clinical study of PL9643 in patients with dry eye disease.
The study is designed to enroll up to 400 patients at multiple U.S.
sites, and top-line results are currently expected second half
calendar 2022.
"We are excited to initiate the MELODY-1 study of PL9643 in
patients suffering from dry eye disease," said Carl Spana, Ph.D., CEO and President of Palatin.
"This is the second melanocortin peptide Palatin has advanced into
Phase 3, demonstrating Palatin's expertise and efficiency in
melanocortin peptide development for indications with unmet medical
need."
The pivotal Phase 3 MELODY-1 clinical study is a multi-center,
randomized, double–masked and vehicle–controlled study evaluating
the safety and efficacy of the melanocortin agonist, PL9643
ophthalmic solution, compared to vehicle in subjects with dry eye
disease (DED). The study design is based on positive Phase 2
results of PL9643 for the treatment of dry eye disease, and an
end-of-phase 2 (EOP2) meeting with the with the U.S. Food and Drug
Administration (FDA), reaching agreement on all key elements of a
pivotal Phase 3 clinical program, including study design,
endpoints, interim assessment, and patient population. In addition,
to support a New Drug Application (NDA) filing, a second phase 3
study (MELODY-2) and long-term safety study (MELODY-3) will be
required. If the program progresses as planned, top-line results
from MELODY-1 would be available second half calendar 2022,
MELODY-2 data read out second half calendar 2023, with a potential
NDA submission first half calendar 2024.
"Progressing PL9643 into Phase 3 is a significant milestone for
the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of
Palatin. "PL9643, with its differentiating factors, could
provide a more tolerable and effective treatment option for
patients suffering from dry eye disease."
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. Dry eye disease 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 dry eye disease
is generally regarded as inadequate by many physicians and
patients, and often requires week 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, MC1r
through MC5r. 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 and natriuretic peptide 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. For additional information regarding Palatin,
please visit Palatin's website at www.palatin.com and follow
Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin, such as
statements about clinical trial plans and potential results for
clinical or pre-clinical programs, 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 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 for
events that occur after the date of this press release.
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SOURCE Palatin Technologies, Inc.