CRANBURY, N.J., April 4, 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 positive results of a
micro-dose study of radiolabeled PL-8177 using an oral,
delayed-release, polymer formulation. The study met all primary and
secondary endpoints. PL-8177 is a patented melanocortin
receptor 1 agonist with potential application in treatment of
ulcerative colitis and other inflammatory bowel diseases.
The main objective of the study was to demonstrate release of
polymer-bound PL-8177 in the lower gastrointestinal tract after
oral administration. Top line data showed favorable
pharmacokinetics, and demonstrated PL-8177 was released in the
lower gastrointestinal tract, supporting oral administration of
PL-8177 using the delayed release polymer formulation.
A secondary objective of the study was also met, demonstrating
that PL-8177 is not systemically absorbed after oral
administration. There was no intact PL-8177 or its metabolite
detected in plasma after oral administration. The oral
formulation was well tolerated and there were no adverse events
observed.
"The results of this study support moving forward with
development of polymer-bound PL-8177 to deliver drug to the lower
gastrointestinal tract to treat ulcerative colitis and other
inflammatory bowel diseases," said Dr. Carl
Spana, President and Chief Executive Officer of Palatin
Technologies. "Importantly, this study demonstrates that our
oral, delayed-release polymer formulation of PL-8177 can deliver
peptide to the diseased region of the bowel, without systemic
uptake. The melanocortin receptor 1 is a novel target for
treating ulcerative colitis and other inflammatory diseases, as it
is present on the interior wall, or lumen, of the colon and lower
gastrointestinal tract."
The lumen of the colon and lower gastrointestinal tract contains
cells with receptors for melanocortin-1, which when activated by
binding of PL-8177 can result in resolution of chronic inflammatory
responses. The delayed release polymer formulation of PL-8177 is
designed to protect the peptide until it reaches the lower
gastrointestinal tract.
This open label study enrolled 24 subjects divided into 6
cohorts of 4 patients each. Blood, urine and feces samples
were analyzed for total radioactivity and radiolabeled PL-8177 and
its metabolite. The percentage of intact radiolabeled PL-8177
and its metabolite was measured at different timepoints following
administration of a single oral microdose of polymer-bound
radiolabeled PL-8177.
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 is
Palatin's lead clinical development candidate for ulcerative
colitis and other inflammatory bowel diseases. PL-8177, a
selective MC1r agonist peptide, is a synthetic cyclic heptapeptide
with demonstrated efficacy in animal inflammatory bowel disease
models. PL-8177 is a potent agonist at human MC1r, with
sub-nanomolar affinity binding and EC50 functional
values.
About Ulcerative Colitis
Ulcerative colitis is a
chronic disease of the large intestine (colon), with inflammation
and ulcerations that can cause significant abdominal pain,
persistent diarrhea, loss of appetite and other symptoms.
Over 700,000 individuals in the United
States are affected by ulcerative colitis, with over 350,000
diagnosed with moderate-to-severe disease. Existing
treatments are not effective in a large portion of patients with
moderate-to-severe ulcerative colitis, with some severe cases
resulting in surgical removal of the colon.
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.