- ~30-40% of ED patients do not respond to PDE5i
treatment
- Published clinical data and mechanisms of action support
clinical study of bremelanotide in combination with a
PDE5i
- Successfully co-formulated bremelanotide with a
PDE5i
- Phase 2 clinical study in PDE5i non-responder ED patients
currently expected to commence in 4Q 2023
CRANBURY, N.J., Aug. 10,
2023 /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 it
has initiated a clinical development program evaluating
bremelanotide, a melanocortin receptor 4 (MCR4) agonist,
co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of
erectile dysfunction (ED) in patients that do not respond to PDE5i
monotherapy.
Published clinical data of the use of bremelanotide and PDE5i
drugs in ED patients, provides support that the combination of
bremelanotide with a PDE5i, two active ingredients that act by
different and distinct mechanisms of action, into a single drug
product, has the potential to be synergistic, at lower doses,
thereby reducing the potential for side effects.
Working with a collaborator, Palatin has developed a
co-formulation of bremelanotide and a PDE5i which can be
administered as a single injection. The initial trial for the
clinical development program for this novel co-formulation will be
a Phase 2 clinical study of bremelanotide co-administered with a
PDE5i in ED patients who have not responded to PDE5i treatment.
This study is currently expected to start in the fourth quarter of
the calendar year 2023.
"PDE5i monotherapy in ED patients using Viagra®,
Cialis® or Levitra® accounts for over
$4 billion of annual sales in
the United States, yet
approximately 30%-40% of patients exhibit little or no response,"
said Carl Spana, Ph.D., President
and Chief Executive Officer of Palatin. "This is a significant
market with substantial unmet medical needs, and we believe that
bremelanotide, co-administered with a PDE5i, would be synergistic
and could benefit these non-responder patients."
"PDE5i use has revolutionized the treatment of ED and is an
effective treatment in two-thirds of men with ED, which means they
are an ineffective treatment in one-third of patients," said
Irwin Goldstein, M.D., a leading
specialist in diagnosing and treating sexual health issues and
Director of San Diego Sexual Medicine. "The PDE5i non-responder
population is substantial, consisting of millions of men with ED,
and is growing. ED patients that fail PDE5i treatment have limited
non-surgical options. I have used both PDE5i drugs and
bremelanotide extensively in my practice for men with ED, and I
believe a novel co-formulation of bremelanotide and a PDE5i, could
be an effective pharmacologic treatment option for the PDE5i
non-responder patients suffering from ED."
Bremelanotide (1.75mg) is the active agent in
Vyleesi®, approved by the U.S. Food and Drug
Administration (FDA) for the treatment of premenopausal women with
hypoactive sexual desire disorder (HSDD).
As the first company to gain FDA approval for a melanocortin
receptor molecule (Vyleesi for HSDD), Palatin has extensive
expertise in the design and development of melanocortin- based
therapeutics and the clinical development, regulatory approval and
commercialization of treatments for sexual dysfunction.
Bremelanotide has been evaluated as a treatment for men with ED
in numerous clinical studies demonstrating statistically and
clinically significant improvements in their erectile function.
This includes a clinical study evaluating bremelanotide in men who
failed PDE5i treatment with significant improvement in the number
of PDE5i failures who achieved successful intercourse. In a second
study, intranasal bremelanotide was co-administered with a PDE5i
and the erectile response with co-administration was statistically
superior to the PDE5i alone. Both mentioned studies have been
published in peer reviewed journals and the references are cited
below.
Relevant publications evaluating bremelanotide co-administered
with a PDE5i or in PDE5i failures include:
- Diamond, LE et al. Co-Administration of Low Doses of
Intranasal PT-141, a Melanocortin Receptor Agonist, and Sildenafil
to Men with Erectile Dysfunction Results in an Enhanced Erectile
Response. Urology 65: 755-759, 2005; and,
- Safarinejad MR et al. Salvage of Sildenafil Failures with
Bremelanotide: A Randomized, Double-blind, Placebo Controlled
Study. J. Urology 179: 1066-1071, 2008.
About Erectile Dysfunction (ED)
Erectile dysfunction
is the consistent inability to attain and maintain an erection
sufficient for sexual intercourse. Up to 35% of men are
non-responsive to standard therapies with phosphodiesterase-5
inhibitors such as sildenafil (Viagra®), vardenafil
(Levitra®) and tadalafil (Cialis®). There are
limited therapeutic options for ED patients non-responsive to
phosphodiesterase-5 inhibitor therapy, including alprostadil for
direct penis injection or urethral suppositories, surgical penile
implants and various devices.
About Vyleesi® (bremelanotide injection) for
Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the
first and only as-needed treatment approved by the FDA for
premenopausal women with acquired, generalized HSDD.
Palatin is actively seeking Vyleesi collaborations for
the United States and for
territories outside the currently licensed territories of
China and Korea. Vyleesi is
licensed to Fosun Pharma in China
and Kwangdong Pharmaceuticals in South
Korea.
Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com and www.vyleesipro.com.
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, such as statements about
combination therapy with bremelanotide and a PDEi5, including
results and potential market, 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.
Palatin Technologies® and Vyleesi® are
registered trademarks of Palatin Technologies, Inc.
All other trademarks are the property of their respective
owners.
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SOURCE Palatin Technologies, Inc.