CRANBURY, N.J., Feb. 19, 2020 /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 and
natriuretic peptide receptor systems, today announced that it has
enrolled the first patient in a Phase 2 clinical trial of topical
PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the
treatment of dry eye disease (DED).
"We are pleased to initiate this Phase 2 study of PL9643
exploring treatment of both the signs of eye damage and the
physical symptoms experienced by patients with dry eye disease,"
commented Carl Spana, Ph.D., President and CEO of Palatin.
"Millions of people suffer from DED and the market is underserved,
with a significant percentage of patients not refilling their
prescriptions for some DED drugs after their initial use. We
believe that PL9643's potentially quick onset to efficacy and more
favorable tolerability and safety profile compared to existing
treatments may allow for substantial penetration of the dry eye
market. We expect to report data from this study in the fourth
quarter of this calendar year."
The Phase 2 study is a multi-center, randomized double-masked
and placebo-controlled study evaluating the efficacy and safety of
PL9643 ophthalmic solution (topical eye drops) compared to placebo
for the treatment of the signs and symptoms of dry eye. The study
is designed to enroll up to 150 participants at three sites in the
US. Patients will be randomized in a 1:1 ratio into two arms,
PL9643 or placebo, and will undergo 12-weeks of treatment. The two
primary endpoints are inferior corneal fluorescein staining and
ocular discomfort. There are several secondary and exploratory
outcome measures as well. For more information about the study,
including inclusion/exclusion criteria, a clinical trial synopsis
can be found on clinicaltrials.gov (NCT04268069).
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 30 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 weeks or months to demonstrate
activity.
About Palatin Technologies, Inc.
Palatin
Technologies, Inc. is a specialized 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 in order to maximize their commercial potential.
For additional information regarding Palatin, please visit
Palatin's website at www.Palatin.com.
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 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 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.