- Dry Eye Disease (DED): PL9643 MELODY-1 Phase 3 Study
- Data Base Lock 2H January
2024
- Topline Data Readout Expected Early 1Q Calendar Year 2024
- Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in
Active UC Patients
- Interim Analysis Data Readout on Track for 1Q Calendar Year
2024
- Topline Results Expected in 2Q Calendar Year 2024
- Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like
Peptide-1 (GLP-1)
- Phase 2 Clinical Study Targeted to Start 1Q Calendar Year
2024
- Topline Results Expected in 2H Calendar Year 2024
- Male Sexual Dysfunction: Bremelanotide Co-Formulated with a
PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients
that do not Respond to PDE5i Monotherapy
- Phase 2 Clinical Study Targeted to Start 1Q Calendar Year
2024
- Topline Results Expected in 2H Calendar Year 2024
- Vyleesi®
- Completed Asset Sale to Cosette Pharmaceuticals for up to
$171 Million
- $12 Million Upfront Plus
Sales-Based Milestones of up to $159
Million
CRANBURY, N.J., Jan. 8, 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 provided a corporate
update, highlighted the Company's key calendar year 2023
accomplishments and outlined its anticipated calendar year 2024
clinical development milestones.
"We made significant operational progress during calendar year
2023 and we believe we are well-positioned for making calendar year
2024 a pivotal and transformative year for Palatin," said
Carl Spana, Ph.D., President and CEO
of Palatin. "Our internal research and development efforts are
focused in areas where we believe we have a high probability of
success, product differentiation and the opportunity for a
substantial return on our investment. Topline data readout for our
Phase 3 PL9643 clinical study for DED is expected early in the
first quarter of calendar year 2024. Our Phase 2 study of oral
PL8177 in patients with UC is expected to have an interim analysis
data readout in the first quarter and topline trial results in the
second quarter of calendar year 2024."
Dr. Spana further commented, "We are excited by the significant
opportunity of melanocortin-based therapeutics for obesity
treatment and believe we are well positioned to deliver selective
and efficacious MCR4 long-acting peptides and orally active small
molecules. We expect to commence a Phase 2 clinical study of a MCR4
agonist plus a GLP-1 in obese patients in the first quarter of
calendar year 2024. In addition, following on our significant
expertise in product development to treat sexual dysfunction, we
expect to commence a Phase 2 clinical study evaluating
bremelanotide co-formulated with a PDE5i for the treatment of ED in
patients that do not respond to PDE5i monotherapy in the first
quarter of calendar year 2024."
The recently announced divestiture of Vyleesi is consistent with
Palatin's strategic decision to concentrate on its robust
development and clinical pipeline. Palatin is now focused on
developing novel therapeutics that modulate the melanocortin
receptor system.
Program Updates and Expected Milestones for 2024
- Anti-Inflammatory / Autoimmune Programs
- PL9643 melanocortin agonist Phase 3 study for the
treatment of DED:
-
-
- Patient enrollment completed (n=570) in Phase 3 MELODY-1
study
- Data base lock second half of January
2024
- Topline data readout expected early first quarter of calendar
year 2024
- Phase 3 safety and efficacy study MELODY-2 and the open label
MELODY-3 study are anticipated to commence patient enrollment in
the second half of calendar year 2024
-
- PL8177 oral melanocortin agonist Phase 2 study for the
treatment of UC:
-
-
- Interim assessment targeted for the first quarter of calendar
year 2024
- Topline data readout is expected in the second quarter of
calendar year 2024
-
- Bremelanotide BREAKOUT Phase 2 study in patients with diabetic
kidney disease:
-
-
- Topline data readout is expected in the second quarter of
calendar year 2024
- Metabolic Program (Obesity)
-
- Presented positive data with bremelanotide, a melanocortin
receptor 4 (MCR4) agonist, plus glucagon like peptide-1 (GLP-1)
showing increased weight loss and greater glucose control above
monotherapy:
-
-
- Phase 2 clinical study targeted to start in the first quarter
of calendar year 2024
- Topline data readout is expected in the second half of calendar
year 2024
- Initiation of investigational new drug (IND) enabling
activities for a novel MCR4 selective long-acting agonist expected
in the second half of calendar year 2024
- Sexual Health Program (Male Sexual Dysfunction)
-
- Initiated a clinical development program evaluating
bremelanotide co-formulated with a PDE5 inhibitor (PDE5i), for the
treatment of erectile dysfunction (ED) in patients that do not
respond to PDE5i monotherapy:
-
-
- Phase 2 clinical study in PDE5i non-responder ED patients is
expected to commence in the first quarter of calendar year
2024
- Topline data readout is expected in the second half of calendar
year 2024
- Vyleesi® (bremelanotide injection) / Hypoactive
Sexual Desire Disorder (HSDD)
-
- Completed asset sale to Cosette Pharmaceuticals for up to
$171 million in December 2023 for female HSDD:
-
-
- $12 million upfront, plus
potential sales-based milestones of up to $159 million based on annual net sales ranging
from $15 million to $200 million
- Eligible to receive regulatory approval milestones of
$10.5 million related to Fosun
($7.5M China) and Kwangdong ($3.0M S. Korea) licenses – Kwangdong completed a
required Phase 3 study in HSDD patients and is preparing a
regulatory approval submission
- Palatin retained rights and use of bremelanotide for obesity
and male erectile dysfunction indications
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 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.