CRANBURY, N.J., July 8, 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 reinitiation
of enrollment of its Phase 2 study with PL9643 for the treatment of
dry eye disease (DED).
After pausing patient recruitment to ensure patient safety
during the initial phases of the COVID-19 pandemic, Palatin has
commenced patient recruitment in its PL9643 Phase 2 clinical study
in subjects with dry eye disease. Patient enrollment is
currently expected to be complete within the next 30-45 days, with
data readout targeted for the fourth quarter of calendar year
2020.
"We are very happy to resume patient
recruitment in 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.
This Phase 2 study is a multi-center, randomized
double-masked, placebo-controlled study evaluating
the safety and efficacy of PL9643 ophthalmic solution
(topical eye drops) compared to placebo for the treatment of the
signs and symptoms of dry eye disease. 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. For more information
about the study, including inclusion/exclusion criteria, a clinical
trial synopsis can be found on clinicaltrials.gov
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,
AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with
AMAG and ability to protect its rights as the Vyleesi licensor,
market potential for product candidates, and potential adverse
impacts due to the global COVID-19 pandemic such as delays in
regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy, 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, transfer of marketing
and sale of Vyleesi in North
America to another pharmaceutical company, sales of Vyleesi
in the United States and elsewhere
in the world, 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.