- Collaboration with The William Harvey
Research Institute and Queen Mary University of London
- PL-8177 displayed pro-resolving and
anti-arthritic effects in rodents
CRANBURY,
N.J., Jan. 10, 2023 /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 Frontiers in Immunology published a
manuscript, "Pro-resolving and anti-arthritic Properties of the
MC1 Selective Agonist PL8177", summarizing data
demonstrating PL8177 provides therapeutic effects in inflammatory
conditions, including arthritis.

Palatin, in collaboration with The William Harvey Research
Institute, Queen Mary University of London, in London,
UK, conducted the study to assess the immunopharmacology of
a PL8177 in vitro and in a mouse model of inflammatory
arthritis. Key findings included PL8177 activation of mouse and
human MC1 receptors and that PL8177 displayed pro-resolving
activity (enhanced macrophage efferocytosis) and counteracted the
inflammatory profile of zymosan-stimulated macrophages, reducing
the release of IL-1β, IL-6, TNF-α and CCL-2. In the context of
joint inflammation, PL8177 reduced the clinical score, paw swelling
and incidence of severe disease as well as the recruitment of
immune cells into the arthritic joint.
"These results demonstrate that melanocortin-based therapies,
and specifically those targeting the MC1 receptor (MC1r), are a
promising strategy to manage chronic inflammatory diseases," said
Carl Spana, Ph.D., President and CEO
of Palatin. "This data adds to the robust body of pre-clinical and
clinical safety and efficacy data for PL8177, demonstrating its
anti-inflammatory and pro-resolving effects, including for
inflammatory arthritis. We are excited to continue the PL8177 Phase
2 clinical trial for patients with ulcerative colitis, as well as
other internal MC1r agonist development programs, to address unmet
medical needs of the many patients suffering from inflammatory
conditions."
The authors on the paper were Jose
Garrido-Mesa and Bethan Lynne
Thomas of The William Harvey Research Institute,
John Dodd and Carl Spana of Palatin, and Mauro Perretti and Trinidad Montero-Melendez of The William Harvey
Research Institute and the Centre for Inflammation and Therapeutic
Innovation, Queen Mary University of London. The citation is
https://www.frontiersin.org/articles/10.3389/fimmu.2022.1078678.
Drugs targeting the melanocortin system have emerged as
promising therapeutics for several conditions, including
inflammatory diseases, obesity and sexual dysfunction, with several
already FDA approved. As illustrated in the publication,
melanocortins are peptides that have anti-inflammatory and
pro-resolving effects. Many of these effects are mediated by the
melanocortin receptor 1 as reported in several experimental
settings. As such, MC1r can be a viable target for the development
of new therapies that mimic endogenous pro-resolving mediators.
Palatin has multiple MC1r agonist candidates in pre-clinical and
clinical development.
Palatin is conducting a Phase 2 multi-center, randomized,
double-blind, placebo-controlled, adaptive design, clinical study
of PL8177, with once daily (QD) oral dosing in adult UC subjects.
The study is designed to enroll up to 28 adult subjects with active
UC from approximately 22 sites. All subjects who meet the
eligibility criteria will be randomized to receive either placebo
or oral PL8177.
The PL8177-205 interim assessment is expected to occur in the
first quarter of calendar year 2023, with final topline data
anticipated in the second 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, 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.
Palatin Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.