- Poster data demonstrates PL9643 positive
effects on signs and symptoms of
dry eye disease
- Consistent clinical efficacy across multiple
signs and symptoms of dry eye along with excellent safety and
tolerability build a differentiating product profile
- Melody-1 Phase 3 clinical study continuing
patient enrollment - final data
second half of 2023
CRANBURY, N.J., April 27,
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 a poster entitled Effectiveness of PL9643 in
Treating the Signs and Symptoms of Moderate to Severe Dry Eye
Disease: Results From 2 Independent Clinical Trials at the
Association of Research in Vision and Ophthalmology (ARVO) Annual
Conference. The authors of the poster are George W. Ousler, MS, Robert Jordan, and Carl
Spana, Ph.D. Mr. Ousler is an employee of Ora, Inc. and Mr.
Jordan and Dr. Spana are employees of Palatin Technologies. The
poster was presented by George
Ousler on April 26, 2023 at
the ARVO conference in New
Orleans. The poster is available on Palatin's website at
www.palatin.com.
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"The presented data supports our excitement about PL9643 ocular
tolerability and broad efficacy and the potential for PL9643 to
become a leading treatment for the many patients that deal with
DED," said Carl Spana, Ph.D.,
President and CEO of Palatin. The excellent ocular tolerability and
efficacy across multiple signs and symptoms of DED distinguishes
PL9643 from currently approved treatments for DED."
The goal of the data analysis of the MELODY-1 Lead In patients
was to confirm the optimal endpoints, hierarchy of the endpoints
and number of patients for the final Phase 3 data analysis. The
data analyses showed statistical significance for multiple sign and
symptom endpoints. The currently planned sample size for MELODY-1
was selected to provide the optimal opportunity for PL9643 to
demonstrate statistical significance for multiple sign and symptom
endpoints. The PL9643 MELODY-1 Phase 3 study is expected to have
topline data in the second half of 2023.
The poster presents data from a completed Phase 2 clinical trial
and from the Lead In population of the ongoing Phase 3 MELODY-1
trial. The data analyses show PL9643 demonstrated effectiveness
across multiple clinical signs and reduced symptomatic ocular pain
indicating that PL9643 is having a positive affect across multiple
regions of the eye, offering a potentially differentiating efficacy
profile from currently available treatments for DED. The magnitude
of the absolute difference between PL9643 and vehicle exceeds what
has been reported for other approved products for several clinical
sign and symptom endpoints.
The safety results from the Phase 2 and initial Phase 3 analysis
show that there are no ocular adverse events related to the use of
PL9643 and no patients discontinued use of PL9643 because of
tolerability issues.
"Based on the safety, ocular tolerability, and efficacy results
from the clinical studies, PL9643 may fill an important unmet need
in patients with DED," said Michael
Raizman, MD, practicing ophthalmologist and CMO of Palatin.
"PL9643's novel mechanism of action potentially protects the ocular
surface from the damaging effects of inflammation and helps resolve
ongoing inflammation."
About Dry Eye Disease (DED)
Dry eye disease is a
common inflammatory disease that, left untreated, can become
extremely painful and lead to permanent damage to the cornea and
vision. DED affects the cornea and conjunctiva of the eye resulting
in irritation, redness, pain, and blurred vision. It is estimated
to affect over 20 million people in the
United States. The disease is characterized by insufficient
moisture and lubrication in the anterior surface of the eye,
leading to dryness, inflammation, pain, discomfort, irritation,
diminished quality of life, and in severe cases, permanent vision
impairment. Existing therapy for DED is generally regarded as
inadequate by many physicians and patients, and often requires
weeks or months to demonstrate activity.
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 and.
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 PL9643 clinical 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 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.