CRANBURY, N.J., June 29, 2021 /PRNewswire/ -- Palatin
Technologies, Inc. ("Palatin") (NYSE American: PTN) a
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin peptide
receptor system, today announced the completion of an End-of-Phase
2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA)
for PL9643 for the treatment of dry eye disease (DED).
The EOP2 meeting scope included all aspects of PL9643's
development plan, with the FDA and Palatin reaching agreement on
all key elements of a pivotal Phase 3 clinical program, including
study design, endpoints, interim assessment, and patient
population. In addition, a potential second Phase 3 study and
long-term safety study were discussed to support a New Drug
Application (NDA). Palatin remains on track to initiate the
Phase 3 program in DED patients during the fourth quarter of
calendar year 2021, with data readout expected in the second half
of calendar year 2022. If the program progresses as planned, an NDA
submission is targeted for the second half of calendar year
2023.
"As a practicing ophthalmologist, I am encouraged by the data to
date on the PL9643 program, which offers much needed optimism for
an effective treatment of dry eye without tolerability issues,"
said Michael Raizman, M.D., Chief
Medical Officer of Palatin. "I look forward to further
demonstrations of PL9643's potential to transform the topical
treatment of DED for the millions of people suffering from the
disease."
"We now have clarity on the registrational path required to
demonstrate the safety and efficacy of PL9643, having reached
agreement with FDA on all key elements of PL9643's pivotal phase 3
program for DED," said Carl Spana,
Ph.D., President and Chief Executive Officer of Palatin. "This is
an important corporate milestone, as we now have a second
melanocortin agonist in phase 3 development, which we believe
validates our strategy which focuses our efforts on the development
of melanocortin based therapeutics for inflammatory and autoimmune
conditions."
PL9643 is a novel melanocortin agonist, delivered to the eye
topically via eyedrops. Palatin previously announced positive
results in its Phase 2 study of PL9643 for the treatment of DED.
Statistically significant improvement in multiple signs and
symptoms was achieved in the moderate to severe patient population
after 2 weeks of dosing and at the 12-week visit. There were no
safety signals identified and PL9643 had excellent ocular
tolerability.
About Melanocortins and Inflammation
The melanocortin
receptor ("MCr") system has effects on food intake, metabolism,
sexual function, inflammation, and immune system responses. 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 significant pharmacological
effects.
Many tissues and immune cells located in the eye express
melanocortin receptors, empowering our opportunity to directly
activate natural pathways to resolve disease inflammation.
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 weeks or months to demonstrate
activity.
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.
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 PL9643, 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/palatin-announces-positive-end-of-phase-2-meeting-with-fda-on-pl9643-for-the-treatment-of-dry-eye-disease-301321681.html
SOURCE Palatin Technologies, Inc.