- In ED patients that do not respond to PDE5i monotherapy
- ~30-40% of ED patients do not respond to PDE5i
treatment
- Data from this Phase 2 clinical study is expected by end of
calendar year 2024
- Published clinical data and mechanisms of action support
clinical study of bremelanotide in combination with a
PDE5i
- Phase 3 clinical study with new co-formulated bremelanotide
plus a PDE5i in ED patients that do not respond to PDE5i
monotherapy expected to start in the 1st half of calendar year
2025
CRANBURY, N.J., June 20,
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, announced the
initiation of a Phase 2 clinical study of bremelanotide (BMT), a
melanocortin 4 receptor (MC4R), co-administered with a
phosphodiesterase 5 inhibitor (PDE5i), for the treatment of
erectile dysfunction (ED) in patients that do not respond to PDE5i
monotherapy. Topline data from the Phase 2 clinical study is
expected by the end of calendar year 2024.
"Approximately 30-40% of ED patients exhibit little or no
response to PDE5i monotherapy, such as Viagra, Cialis, and
Levitra," said Carl Spana, Ph.D.,
President and Chief Executive Officer of Palatin. "These PDE5i
monotherapy drugs account for over $4
billion of annual sales, yet PDE5i monotherapy does not work
for a significant portion of ED patients. This represents a
substantial unmet medical need for more effective ED treatments.
Based on our clinical data and mechanisms of action research, we
believe that BMT combined with a PDE5i is synergistic and will be a
clinically meaningful ED treatment for non-responders to current
PDE5i monotherapy."
The Phase 2 clinical trial is designed to enroll approximately
50 patients to be treated with BMT co-administered with a PDE5i in
an open-label, dose escalation study treating men with ED who are
considered non-responders to PDE5i monotherapy treatment. The
clinical study is being conducted under an investigator-sponsored
Investigational New Drug (IND) and has Food and Drug Administration
(FDA) clearance and Institutional Review Board (IRB) approval. The
study's primary objective is to assess the safety and efficacy of
BMT co-administered with a PDE5i for the treatment of ED in males
who have not adequately responded to prior PDE5i monotherapy.
"ED has become more prominent over the last several decades,
especially in younger adults, and represents a mounting health
concern causing a significant effect on men's quality of life,"
said Jed Kaminetsky, MD, FACS,
Urologist, Director of Research, Integrated Medical Professionals,
a Division of Solaris Health and the clinical study lead
investigator. "Many patients in my practice are seeking better
results from their ED treatment. Men with more severe ED do not
respond as well using a PDE5i and have limited non-surgical
options. I have used bremelanotide in my practice for men with ED.
I believe the combination of bremelanotide with a PDE5i could
potentially be an effective treatment option for the PDE5i
non-responders suffering from ED."
Palatin has conducted multiple clinical studies of monotherapy
BMT and combination therapy BMT plus a PDE5i in men with ED and
observed statistically significant and clinically meaningful
effects on improving erectile function. In addition, sub-cutaneous
bremelanotide 1.75 mg (Vyleesi®) is approved by the FDA
for the treatment of hypoactive sexual desire disorder (HSDD) in
pre-menopausal women and has demonstrated an increase in sexual
desire and decrease in distress associated with low desire.
Palatin has developed a new co-formulation of bremelanotide and
a PDE5i which can be administered as a single injection. An IND for
this novel co-formulation for the treatment of ED is expected to be
filed with the FDA later this calendar year and a potential Phase 3
clinical study in ED patients who do not respond to PDE5i
monotherapy is expected to start in the first half of calendar year
2025.
About Erectile Dysfunction (ED)
Erectile dysfunction
is the consistent inability to attain and maintain an erection
sufficient for sexual intercourse and affects an estimated 30
million men in the United States,
according to the Centers for Disease Control and Prevention.
Approximately 30-40% of men are non-responsive to standard
therapies with phosphodiesterase-5 inhibitors (PDE5i) such as
sildenafil (Viagra®), vardenafil (Levitra®)
and tadalafil (Cialis®). There are limited therapeutic
options for ED patients non-responsive to PDE5i therapy, including
alprostadil for direct penis injection or urethral suppositories,
surgical penile implants and various devices.
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, 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.