CRANBURY, N.J., Nov. 8, 2018 /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 Phase 1, first-in-human
results of a single and multiple ascending-dose study of PL-8177, a
patented melanocortin receptor 1 agonist with the potential
application of treating ulcerative colitis and other inflammatory
diseases. The data of subcutaneous administration of PL-8177
demonstrated favorable pharmacokinetics and pharmacodynamic
properties and no safety or tolerability concerns were
reported.
The objective of the Phase 1 study was to assess the safety and
tolerability of PL-8177 and evaluate the pharmacokinetics and
systemic exposure following both a single-ascending dose (SAD) and
multiple-ascending doses (MAD) of PL-8177.
"Meeting all safety and study objectives of subcutaneous
administration of PL-8177 is an important first step in the
development of our second melanocortin peptide," said Dr.
Carl Spana, CEO of Palatin
Technologies. "We are very excited to continue development of
PL-8177 and explore additional treatment opportunities. This
demonstrates our expertise in and our commitment to the development
of a robust pipeline of novel peptides targeting the melanocortin
system. Our expansive library of MC1r peptides has the potential to
treat a wide variety of inflammatory diseases, and we believe will
continue to show positive results with further development."
The study enrolled 36 subjects who participated in the SAD stage
and 20 subjects were enrolled and participated in the MAD stage of
the randomized, double-blind and placebo-controlled Phase 1 study.
All subjects in the SAD and MAD cohorts completed dosing.
Overall, PL-8177 was well-tolerated when administered as a single
and multiple ascending dose regimen, and a distinct pharmacokinetic
profile was established in both the SAD and MAD parts of the
study. No serious adverse events were reported in the SAD or
MAD parts of the study.
PL-8177, a selective melanocortin receptor 1 (MC1r) agonist
peptide, is Palatin's lead clinical development candidate for
ulcerative colitis and other inflammatory bowel diseases. Evolving
research suggests that the MC1r system plays an important role in
anti-inflammatory responses and immunoregulation, including
resolution of innate pro-inflammatory immune responses.
Data from a separate clinical study investigating an oral
formulation of PL-8177 is currently expected by the end of
2018.
About PL-8177
PL-8177 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.