CRANBURY, N.J., Dec. 15, 2020 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a specialized
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin peptide
receptor systems, today announced positive results in its Phase 2
study of PL9643 for the treatment of dry eye disease (DED).
Statistically significant improvement in multiple signs and
symptoms was achieved in the moderate to severe patient population
after 2 weeks of dosing and at the 12-week visit. There were no
safety signals identified and PL9643 had excellent ocular
tolerability. However, statistical significance for the primary
endpoints was not reached in the overall enrolled population that
included mild, moderate, and severe patients, as measured at the
12-week primary evaluation visit.
"This was our first study evaluating a melanocortin agonist in
an ocular disease and we are pleased that the key goals of this
study were met, which was providing significant clinical evidence
of efficacy, safety, and tolerability in a meaningful patient
population - patients suffering from moderate to severe DED,"
stated Carl Spana, Ph.D., President and CEO of Palatin.
"Importantly, we have a clear development and regulatory path
forward. With approximately 20 million adults in the United States currently suffering from
DED, the majority being moderate to severe patients, and up to 50%
discontinuing treatment due to slow onset, lack of efficacy or
intolerance, PL9643's potentially quick onset of efficacy and
excellent tolerability profile are differentiating factors to
current approved therapies."
In the sub-population of moderate to severe patients (N=61),
PL9643 achieved statistical significance (P value <0.05 vs.
vehicle) at week 2 and week 12 for multiple signs, including
inferior (the primary sign endpoint), superior, and total corneal
staining, temporal, nasal and total conjunctival staining, tear
film break-up time, and multiple ocular symptoms, including ocular
discomfort. Additionally, multiple sign and symptom measures
trended towards significance (P value <0.1 vs. vehicle). Based
on these positive trial results, Palatin plans to initiate a Phase
2/3 trial in the United States in
mid calendar year 2021.
"This work, utilizing the melanocortin pathway, is an excitingly
novel departure from all other dry eye therapeutic strategies,"
said Kenneth Kenyon, M.D., Principal
Investigator for the study, cornea specialist at New England Eye
Center and Professor of Ophthalmology, Tufts
University School of Medicine. "The demonstrated consistency
of improved outcomes across multiple sign and symptom time points
is most impressive. Significant improvement in both corneal and
conjunctival staining is highly relevant, as it affects both vision
and irritative symptoms, especially so in these more advanced dry
eye patients. The emerging profile of PL9643, with its rapid
therapeutic onset and excellent tolerability profile, is a
potentially distinct advance in dry eye therapy."
"The Phase 2 study of PL9643 has provided guidance on the
clinical and regulatory pathway forward for this program. The
results identify the most appropriate patient population,
endpoints, and timepoints for the next study. We look forward
to working with Palatin to confirm the therapeutic potential of
PL9643 in treating the signs and symptoms of dry eye" said
George Ousler, Senior Vice
President, Anterior Segment at Ora, Inc.
This Phase 2 study was a multi-center, randomized, double-masked
and vehicle-controlled study evaluating the efficacy and safety of
PL9643 ophthalmic solution (topical eye drops) compared to vehicle
for the treatment of the signs and symptoms of dry eye. The study
enrolled 160 participants randomized in a 1:1 ratio into two arms,
PL9643 or vehicle, at four sites in the
United States. Patients underwent 12 weeks of daily
treatment. The intent to treat (ITT) population included all
patients with mild-moderate-severe DED. The two prespecified
primary endpoints were improvement in inferior corneal staining
(sign) and ocular discomfort (symptom) as measured at the 12-week
primary evaluation visit. There were multiple secondary sign and
symptom outcome measures as well.
Trial results demonstrated an excellent safety and tolerability
profile. There were no serious adverse events associated with study
treatment observed. Three patients on placebo and one patient on
PL9643 (not deemed to be drug related) discontinued from the study.
Importantly, there were no ocular, drug-related adverse events in
the PL9643 subjects.
Detailed study results are anticipated to be presented at the
Association for Research in Vision and Ophthalmology (ARVO) 2021
Annual Meeting.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
December 15, 2020 at 8:00 a.m. Eastern Time to discuss its Phase 2
study of PL9643 in greater detail. Individuals interested in
listening to the conference call live can dial 1-800-367-2403
(US/Canada) or 1-334-777-6978
(international), conference ID 2038353. 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. A telephone
and audio webcast replay will be available approximately one hour
after the completion of the call. To access the telephone replay,
dial 1-888-203-1112 (US/Canada) or
1-719-457-0820 (international), passcode 2038353. The webcast and
telephone replay will be available through December 22, 2020.
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. Dry eye disease 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 dry eye disease is generally regarded as inadequate by
many physicians and patients, and often requires weeks or months to
demonstrate activity.
About Ora, Inc.
Ora is the world's leading full-service ophthalmic CRO and
product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, Ora has helped
clients earn 45 product approvals. Ora supports a wide array of
organizations, from start-ups to global pharmaceutical and device
companies, to efficiently bring their new products from concept to
market. Ora's pre-clinical and clinical models, unique
methodologies and regulatory strategies have been refined and
proven across thousands of projects. For more information about
Ora, please go to www.oraclinical.com.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized 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.
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 clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, market potential for product candidates,
and potential adverse impacts due to the global COVID-19 pandemic
such as delays in regulatory review, manufacturing and supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy, 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.