- Topline data currently expected late 4Q calendar
2023
- Interim analysis of first 120 patients
demonstrated:
-
- Excellent safety and tolerability product
profile
- Potential for PL9643 to address multiple signs and symptoms
of dry eye disease
CRANBURY, N.J., Sept. 7,
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 that
enrollment in the PL9643 MELODY-1 Phase 3 study in dry eye disease
(DED) is complete, with 570 patients enrolled. The Company is on
track to release topline results by the end of the fourth quarter
of calendar year 2023.
"We are committed to addressing unmet needs of DED patients. We
believe that PL9643, with its novel mechanism of action and
differentiated product profile for efficacy, safety and ocular
tolerability, if approved, will be a first-in-class treatment
option for the millions of patients who suffer from DED," said
Carl Spana, Ph.D., President and CEO
of Palatin. "We are optimistic about results of the Phase 3 PL9643
data based on the positive interim analysis and are pleased to have
completed enrollment so promptly. I thank the patients,
investigators, clinical site staff, and our employees for achieving
this important milestone."
Palatin previously announced positive interim analysis data and
recently presented portions of this data at the ARVO 2023
conference in April 2023. The
excellent ocular tolerability and efficacy across multiple signs
and symptoms of DED distinguishes PL9643 from currently approved
treatments for DED.
Michael Raizman, MD, practicing
ophthalmologist and Chief Medical Officer of Palatin, stated,
"Given the key role melanocortins play in the resolution of
inflammation, we are very encouraged by the findings in the Phase 2
study and the interim analysis of the initial 120 patients in the
Phase 3 study, which demonstrated the potential for PL9643 to
address both signs and symptoms associated with DED as a possible
treatment for the millions of patients not satisfied with current
commercial therapies."
Topline data for the PL9643 MELODY-1 Phase 3 Study is
anticipated by the end of the fourth quarter of calendar year 2023.
Assuming positive results, the remaining Phase 3 studies are
expected to be completed by the end of calendar year 2024 and early
calendar year 2025, with a New Drug Application submission to the
U.S. Food and Drug Administration (FDA) for approval mid-year
calendar 2025.
The pivotal Phase 3 MELODY-1 clinical study, being conducted in
the U.S., is a multi-center, randomized, double–masked and
vehicle–controlled study evaluating the safety and efficacy of the
melanocortin agonist, PL9643 ophthalmic solution, compared to
vehicle in patients with moderate-to-severe DED, for multiple sign
and symptom endpoints. The study design is based on positive Phase
2 results of PL9643 for the treatment of DED, and an end-of-phase 2
meeting with the FDA on key elements of the pivotal Phase 3
clinical program.
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.
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
results, anticipated dates, and potential markets, 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.