- On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint
Met, Statistical Significance (P<0.025)
- Multiple Secondary Symptom Endpoints Met, Statistical
Significance (P<0.025)
- On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and
Secondary Sign Endpoints Not Met
- PL9643 Demonstrated Superiority Over Vehicle in Multiple
Sign Endpoints
- Excellent Safety and Tolerability Profile
- Future Discussions Planned with FDA Regarding Regulatory
Approval Path
- Company to Host Conference Call at 8:30 a.m. ET
Today
CRANBURY, N.J., Feb. 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
results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial
evaluating the safety and efficacy of PL9643 versus vehicle in the
treatment of dry eye disease (DED).
MELODY-1 had two co-primary efficacy endpoints: one clinical
symptom (pain) and one clinical sign (conjunctival lissamine green
staining), as well as multiple other symptom and sign secondary
endpoints of DED. Duration of treatment was 12 weeks with a 4-week
run-in period. Analysis of the data indicated that both age and sex
needed to be accounted for in the primary statistical analysis,
(60% of the subjects were over age 60; 68% of the subjects were
female). After adjusting the Intent-to-Treat (ITT) analysis for age
and gender, PL9643 treatment demonstrated clinically meaningful
(visual analog score reduction of >10 points from baseline) and
statistically significant results for the co-primary symptom
endpoint of pain (p<0.025) and multiple other symptom endpoints.
PL9643 treatment for the co-primary sign endpoint and secondary
sign endpoints demonstrated positive treatment effects over vehicle
in the ITT population but did not achieve statistical significance.
In the unadjusted planned analyses, the co-primary endpoints and
secondary endpoints did not reach statistical significance.
"Even with a high vehicle response, PL9643 treatment was
clinically meaningful and statistically significantly effective on
an ITT basis in reducing patient symptoms for the co-primary pain
endpoint and multiple other symptom endpoints," said Carl Spana, Ph.D., President and CEO of Palatin.
"We are pleased that PL9643 treatment demonstrated excellent safety
and tolerability data, including superior efficacy results compared
to vehicle across multiple sign endpoints."
"It is important to note that it is rare for one clinical study
in DED to show efficacy for both a sign and a symptom. While
additional analyses are ongoing, the initial results reinforce the
potential of PL9643 as a treatment to address both symptoms and
signs of DED," continued Dr. Spana. "Our comprehensive data
analysis is ongoing, and upon completion, we plan to meet with the
FDA to discuss and get feedback on the design of the next pivotal
Phase 3 clinical trial. Furthermore, we will continue with our
efforts for a collaboration partner for our DED program."
Safety analysis indicated PL9643 was well-tolerated. There were
fewer ocular treatment related adverse events in the PL9643 arm
(5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer
study discontinuations in the PL9643 arm (7.0%, N=20/288) compared
to vehicle (11.1%, N=32/287).
PL9643 represents an opportunity to bring relief to dry eye
sufferers. While DED is one of the most common ocular disorders,
affecting an estimated 38 million people in the U.S., only about 18
million are diagnosed and less than 10% of those diagnosed are
treated with a prescription product. This shows the significant
unmet medical need for an effective treatment that also has an
excellent safety and tolerability profile.1
The data from the pivotal Phase 3 MELODY-1 trial was a
multi-center, randomized, double–masked and vehicle–controlled
study that enrolled 575 patients at sites in the U.S. The trial
evaluated 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,
after treatment for 12 weeks. The study design was 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.
Conference Call /
Webcast
Palatin will host a conference call and audio
webcast on February 28, 2024, at 8:30
a.m. Eastern Time to discuss the PL9643 Phase 3 clinical study
results in greater detail. Individuals interested in listening to
the conference call live can dial 1-888-506-0062
(US) or 1-973-528-0011 (International), Participant
Access Code: 295124. The audio webcast and
replay can be accessed by logging on to the "Investor-Webcasts"
section of Palatin's website at http://www.palatin.com or by
clicking here. A telephone and audio webcast replay will be
available one hour after
the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331
(International), Replay Passcode 50021. The webcast and telephone
replay will be available through March 13,
2024.
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 weeks or months to demonstrate
activity.
References
1. Market Scope 2023 Dry
Eye Product Market Review; does not include OTC artificial tears
and other Rx anti-inflammatory and tear stimulants.
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, 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. To learn more about Palatin, please visit us
on www.Palatin.com and follow us 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, including PL9643,
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 agencies 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.