CRANBURY, N.J., June 6, 2019 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing targeted, receptor-specific peptide therapeutics
for the treatment of diseases with significant unmet medical need
and commercial potential, today announced that the U.S. Food and
Drug Administration (FDA) granted orphan drug designation for
PL-8177 for the treatment of non-infectious intermediate,
posterior, pan and chronic anterior uveitis. Non-infectious uveitis
is a group of inflammatory diseases that produces swelling and
destroys eye tissue and can result in vision loss.
"We are very pleased to receive our first orphan drug
designation for a melanocortin agonist peptide from the FDA," said
Dr. Carl Spana, President and Chief
Executive Officer of Palatin Technologies. "Unlike corticosteroids,
immunosuppressive agents, and biological therapies targeting
specific cytokines or receptors, melanocortin receptor 1 peptides
work to resolve chronic inflammations and restore normal immune
function. We look forward to initiating clinical trials with
PL-8177 for non-infectious uveitis, a high medical need disease
with limited treatment options."
Palatin has conducted a single and multiple ascending-dose Phase
1 study with PL-8177 under an investigational new drug (IND)
application for ulcerative colitis. Palatin plans to file an IND
application for non-infectious uveitis with the FDA in the third
quarter of calendar year 2019, and initiate a Phase 2
clinical study in the first half of calendar year 2020. In
both animal studies and Phase 1 subcutaneous studies with PL-8177
no safety or tolerability concerns were reported.
PL-8177 has been evaluated in animal models of experimental
autoimmune uveitis, a model presenting certain clinical features of
human uveitis. In these studies, PL-8177 showed reduction of
inflammation and restoration of normal retinal structure. Spana C,
Taylor AW, Yee DG, Makhlina M, Yang W and Dodd J (2019) Probing the
Role of Melanocortin Type 1 Receptor Agonists in Diverse
Immunological Diseases. Front. Pharmacol. 9:1535.
doi: 10.3389/fphar.2018.01535.
About Orphan Drug Designation
The Orphan Drug
Designation program provides orphan status to drugs intended for
the safe and effective treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in
the United States. Orphan drug
status provides benefits to drug developers including assistance in
the drug development process, tax credits for clinical costs,
exemptions from certain FDA fees and seven years of marketing
exclusivity.
About PL-8177
Evolving research suggests that the
melanocortin receptor 1 (MC1r) system plays an important role in
anti-inflammatory responses and immunoregulation, including
resolution of innate pro-inflammatory immune responses. PL-8177, a
selective MC1r agonist peptide, is a synthetic cyclic heptapeptide
with demonstrated efficacy in animal experimental autoimmune
uveitis disease models. PL-8177 is a potent agonist at human MC1r,
with sub-nanomolar affinity binding and EC50 functional
values. PL-8177 is being investigated in an oral formulation for
treatment of ulcerative colitis and other inflammatory bowel
diseases, and in a subcutaneous injection formulation for treatment
of non-infectious uveitis.
About Non-Infectious Uveitis
Non-infectious uveitis is
a group of inflammatory diseases not due to an active infection
that produces swelling and destroys eye tissue. The disease is
caused by inflammatory responses inside the eye, which may be
initiated by autoimmune responses, responses to infections or
tumors within the eye or other parts of the body, physical injury
or toxins. Uveitis is classified by where it occurs in the eye,
including intermediate, posterior, pan uveitis and chronic anterior
uveitis. Uveitis can be associated with several diseases,
including autoimmune diseases. Initial non-infectious uveitis
symptoms include blurred vision, eye pain, dark floating spots in
vision and light sensitivity. Uveitis can cause vision loss or
blindness if left untreated.
About Palatin Technologies, Inc.
Palatin Technologies,
Inc. is a biopharmaceutical company developing targeted,
receptor-specific peptide therapeutics 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 potential clinical indications for PL-8177,
clinical trial results with PL-8177, 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 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.