- Independent Data Monitoring Committee Recommends Continuing
Study with Sample Size Target of up to 350 Patients – up to
Additional 230 Patients to be Enrolled
- No Safety Concerns Identified
- Topline Results Currently Expected Second Quarter Calendar
2023
CRANBURY, N.J., Aug. 16,
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 and natriuretic peptide receptor
systems, today announced the results of a planned interim analysis
of the Phase 3 pivotal study of PL9643 (MELODY-1) in patients with
dry eye disease (DED). The interim analysis included an assessment
and review by the independent Data Monitoring Committee (DMC) of
the efficacy and safety of the first 120 patients who had completed
treatment. Based on their review, the DMC recommended the study
continue with a study sample size target of up to 350 patients. No
safety concerns were identified by the DMC.
The DMC's primary objective was to provide a recommendation on
the final sample size based on an interim assessment using a
conditional power modeling approach. The DMC had the option to
recommend a final sample size of up to 600 patients. The DMC
performed their assessment on the first 120 patients to complete
the study and based on their recommendation, Palatin plans to
enroll up to an additional 230 patients in the study for a final
sample size of 350 patients. Topline results are expected in the
second quarter of calendar 2023.
"We are highly encouraged by the DMC's recommendation to
continue enrolling patients in this ongoing trial. The emerging
data, including the safety and ocular tolerability, indicate that
PL9643 could be a potentially safe and effective treatment for
patients with DED," said Carl Spana,
Ph.D., President and CEO of Palatin. "Based on trial results to
date, we believe PL9643, with its differentiating factors, could
provide a fast-acting and well-tolerated treatment option for the
millions of patients suffering from DED, and we look forward to
presenting topline results of this Phase 3 trial in the second
quarter of calendar 2023."
The pivotal Phase 3 MELODY-1 clinical study 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. The study design is based on positive Phase
2 results of PL9643 for the treatment of DED, and an end-of-phase 2
(EOP2) meeting with the U.S. Food and Drug Administration (FDA),
reaching agreement on all key elements of a 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 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 and natriuretic peptide
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 PL9643, 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.
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SOURCE Palatin Technologies, Inc.