- Preclinical data shows efficacy in animal models of
ulcerative colitis
- Human pharmacokinetic data show oral formulation releases
PL8177 in colon
CRANBURY, N.J., Oct. 24,
2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE
American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin receptor system, today announced that
John Dodd, Ph.D. presented the
poster "Efficacy of the Melanocortin Receptor Agonist PL8177 as a
Potential Therapy for Gastrointestinal Inflammatory Diseases" at
the American College of Gastroenterology annual meeting in
Charlotte, North Carolina.
The data presented demonstrated that in animal models of
ulcerative colitis, oral PL8177 was efficacious in reducing colonic
damage and inflammation. In addition, in a Phase 0 human
pharmacokinetic study, the oral formulation of PL8177 was released
in the colon and importantly, did not enter into systemic
circulation. The detailed PL8177 preclinical data has been accepted
for publication in an upcoming peer reviewed scientific
publication.
The poster can be found on Palatin's website
www.palatin.com.
"We are very proud of the quality of our research and clinical
development work and for the opportunity to present at such an
important meeting," stated Carl
Spana, Ph.D., President and CEO of Palatin. "The
presentation summarizes the data that supports the potential of
PL8177 as a treatment option for ulcerative colitis patients as an
alternative therapy to immunosuppressive treatments, which have
significant safety and tolerability concerns."
An oral formulation of the melanocortin-1 receptor agonist
(MC1r) PL8177 is being evaluated in the Phase 2 clinical study
PL8177-205 in patients with ulcerative colitis. An interim
assessment is currently expected to occur in the first quarter of
calendar year 2023, with final topline data anticipated in the
third quarter of calendar year 2023. Additional trial information,
including inclusion and exclusion criteria, can be found at
https://clinicaltrials.gov/ via the identifier NCT05466890.
About PL8177
PL8177 is a synthetic cyclic heptapeptide with demonstrated
efficacy in multiple animal inflammatory bowel disease models.
PL8177 is a potent, selective agonist at the human melanocortin
receptor-1 (MC1r), with sub-nanomolar affinity binding and
EC50 functional values. Palatin data demonstrates
that the oral formulation of PL8177 was protected from degradation
in the stomach and small intestine and delivered to the large
intestine and colon over an extended period. In addition, orally
administered PL8177 had a significant effect on resolving
inflammation in a rat bowel inflammation model.
PL8177 in oral formulations has demonstrated repeated, robust
efficacy in ulcerative colitis disease models. MC1r is found on
epithelial cells and resident macrophages of the colon which are
accessible from the lumen of the colon. Orally administered PL8177
is not systemically absorbed. PL8177 has the potential for
excellent efficacy without safety concerns.
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. An estimated 1 million 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 substantial portion of patients
with moderate-to-severe ulcerative colitis, with certain severe
cases resulting in surgical removal of the colon.
About Melanocortin Receptor
Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on
inflammation, immune system responses, metabolism, food intake, and
sexual function. 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 medically significant pharmacological effects. Many tissues
and immune cells located throughout the body, including the gut,
kidney and eye, express melanocortin receptors, empowering our
opportunity to directly activate natural pathways to resolve
disease inflammation.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin 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 and follow Palatin on Twitter at
@PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin, such as
statements about PL8177 clinical trials and results, 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.
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SOURCE Palatin Technologies, Inc.