– Preclinical data presented shows
PL8177 was found to be efficacious in animal models of inflammatory
bowel disease
– Clinical data confirms PL8177 oral
formulation is delivered and contained in the colon
– Phase 2 clinical study data readout in
2H2023
CRANBURY, N.J., May 9, 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 the presentation of the poster
"Efficacy of the Melanocortin Receptor Agonist PL8177 as a
Potential Therapy for Gastrointestinal Inflammatory Diseases" at
the Digestive Disease Week annual meeting May 6-9, 2023 in Chicago, Illinois. The poster was presented by
John Dodd, Ph.D., Senior Vice
President of Preclinical Research at Palatin. The poster can be
found on Palatin's website www.palatin.com.
The data shows the high potency of PL8177, and lack of systemic
absorption, which makes a delayed-release microparticle oral
formulation of the melanocortin-1 receptor (MC1r) agonist
PL8177 a promising new candidate for clinical development for the
treatment of inflammatory bowel disease.
In preclinical studies in rat models of ulcerative colitis, oral
PL8177 was found to be efficacious in reducing colonic damage and
inflammation. In rats and dogs, data showed that oral PL8177 is
released in the lower GI tract where it can exert its effect on
inflammation. Clinical data presented in the poster shows that oral
PL8177 was released in the GI tract and did not reach systemic
circulation.
"This data is a further example of the potential of the
melanocortin system as a target for novel treatments for
inflammatory diseases," said Carl
Spana, Ph.D., President and CEO of Palatin. "We are looking
forward to the data from an ongoing phase 2 study and the potential
of PL8177 as a novel treatment for inflammatory bowel disease."
A phase 2 study, PL8177-205, is currently enrolling patients. An
interim assessment and topline data is anticipated in the second
half of 2023. Additional trial information, including inclusion and
exclusion criteria, can be found at https://clinicaltrials.gov/ via
the identifier NCT05466890.
Digestive Disease Week® (DDW) is the largest
international gathering of physicians, researchers and academics in
the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American
Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA), the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), the meeting showcases more than 5,000
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org.
About PL8177
PL8177 is a synthetic cyclic heptapeptide with demonstrated
efficacy in multiple animal inflammatory bowel disease models.
PL8177 is a potent, selective agonist of the human melanocortin-1
receptor, 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. Drugs based on melanocortin agonists have
been approved by the FDA for treating several conditions, including
female sexual dysfunction, inflammatory/autoimmune diseases, and
rare forms of genetic obesity.
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 preclinical and clinical results for
ulcerative colitis and gastrointestinal inflammatory diseases, 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 events that occur after the date of this
press release.
Palatin Technologies® is a registered trademark of
Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.