- FDA & Palatin agree on clear regulatory path for PL9643
NDA submission in DED
- FDA confirms acceptability of protocols and endpoints for
remaining MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Trials
in DED
- Currently anticipate patient enrollment to start in 4Q
calendar year 2024
- Topline results currently expected in 4Q calendar year
2025
CRANBURY, N.J., Aug. 28,
2024 /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
receipt of FDA correspondence confirming the acceptability of the
protocols and endpoints for signs and symptoms of PL9643 Phase 3
pivotal clinical trials for dry eye disease (DED). The remaining
Phase 3 clinical trial program consists of two Phase 3 studies,
MELODY-2 and MELODY-3, and include sign and symptom endpoints in
each study.
"We are pleased to have concluded a positive Type C meeting with
the FDA and agreement on the remaining two Phase 3 trial protocols,
including the sign and symptom endpoints, for PL9643 for the
treatment of patients with DED," said Carl
Spana, Ph.D., President and Chief Executive Officer of
Palatin. "Current prescription options for DED are generally
regarded as inadequate by many eye care professionals and patients
due to low treatment efficacy, slow onset of action and/or poor
tolerability. PL9643, with its early onset of efficacy for both
signs and symptoms, and its excellent ocular safety and
tolerability profile, is positioned as a highly differentiated
product with an opportunity to bring relief to millions of dry eye
sufferers."
Patient enrollment in MELODY-2 and MELODY-3 are currently
expected to begin in the fourth quarter of calendar year 2024,
resulting in topline results available by year-end calendar 2025.
If recruitment goals are met and the trial results are successful,
an NDA submission in the first half of calendar year 2026 would be
anticipated.
Palatin successfully completed MELODY-1, its first Phase 3
study, in February 2024. The
co-primary symptom endpoint of pain met statistical significance
(P<0.025) and 7 of 11 secondary symptom endpoints met
statistical significance (P<0.05), at the 12-week treatment
period. Data from MELODY-1 demonstrated a rapid onset of efficacy
and multiple symptom endpoints, including the co-primary pain
endpoint, which met statistical significance (P<0.05) at
the 2-week timepoint and continued to improve over the 12-week
treatment period. Also, at the 2-week timepoint, multiple sign
endpoints, including all 4 fluorescein staining endpoints, met
statistical significance (P<0.05). Importantly, PL9643 treatment
demonstrated an excellent safety and tolerability profile.
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. 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 months to demonstrate activity.
Dry eye disease is one of the most common ocular surface
disorders, affecting an estimated 38 million adults in the United States and an estimated 719 million
more adults globally. 1While once considered a disease
of aging populations, modern advancements, such as prolonged
digital screen time, have contributed to a significant rise in DED
across age and gender. 2Many existing prescription
options for dry eye disease are generally regarded by many eye care
professionals and patients as inadequate due to low treatment
efficacy, slow onset of action and/or poor
tolerability.3
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,
MCR1 through MCR5. 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, like 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 Technologies, Inc., such as
statements about Palatin products in development, clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, and market potential for product candidates
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.
References
- Market Scope 2023 Dry Eye Product Market Review; does not
include OTC artificial tears and other Rx anti-inflammatory and
tear stimulants.
- The Relationship Between Dry Eye Disease and Digital Screen Use
- PMC (nih.gov)
- Improved Dry Eye Drugs for 2022 and
Beyond; https://www.aao.org/eye-health/tips-prevention/new-dry-eye-treatments-ocular-surface-disease
Palatin Technologies® is a registered trademark of
Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.