Study Designed to Evaluate the Safety,
Tolerability, and Efficacy with PL8177 Oral Colon Delivery in Adult
Subjects with Active Ulcerative Colitis
Oral PL8177 May Provide a Safe and Tolerable
Treatment Option for Ulcerative Colitis Patients
CRANBURY, N.J., Sept. 8,
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 the
initiation of a Phase 2 clinical study of PL8177, a potent
melanocortin-1 receptor agonist, in ulcerative colitis (UC). The
study will evaluate the safety, tolerability, efficacy,
pharmacokinetics, and biomarkers of orally administered PL8177 in
adult patients with active UC. Clinical sites participating in the
study have been activated, with screening and recruitment of
potential patients underway.
"We are excited to advance oral PL8177, a potent, selective
melanocortin-1 receptor agonist, into a Phase 2 clinical trial in
patients with UC, an inflammatory bowel disease that affects an
estimated one million people in the
United States," stated Carl
Spana, Ph.D., President and CEO of Palatin. "The
melanocortin system plays an important role in the resolution of
inflammation. The oral formulation of PL8177 is targeting
melanocortin-1 receptors on the luminal surface of colon epithelial
cells. In a prior phase 1 clinical study, the oral formulation
successfully demonstrated sustained delivery of PL8177 to the lumen
of the colon with no systemic exposure. Our goal is to
establish PL8177 as a safe and tolerable treatment for patients
eliminating or delaying immunosuppressive treatments that have
safety and tolerability concerns."
The Phase 2 study is a multi-center, randomized, double-blind,
placebo-controlled, adaptive design, parallel group 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 initiation of Palatin's second clinical program evaluating
a melanocortin based therapeutic in an inflammatory indication is
an exciting milestone. We continue to compile compelling data that
strengthens our belief in the potential for melanocortin
therapeutics as safe and effective treatments for inflammatory and
autoimmune diseases," concluded Spana.
The study uses an adaptive design with an interim assessment by
an independent data monitoring committee after the initial 16
subjects have completed the 8-week evaluation visit. The efficacy
evaluations and endpoints are in line with the latest FDA Draft
Guidance for Industry: Ulcerative Colitis: Developing Drugs for
Treatment (April 2022), including
the primary efficacy endpoint the Mayo Endoscopic Subscore, which
evaluates the level of disease in the colon mucosa.
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 (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 in the eye (and other
places, for example the gut and kidney) 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 clinical trial plans and potential results for
PL8177, 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.