- Dry Eye Disease (DED): PL9643
- MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies
- FDA Confirms Protocols and Endpoints
- Targeting Enrollment Start in 4Q Calendar Year 2024
- Topline Results Anticipated 4Q Calendar Year 2025
- Potential Collaboration/Funding Discussions Ongoing
- Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor
(MC4R) Agonist + Glucagon Like Peptide-1 (GLP-1)
- Patient Dosing Commenced 3Q Calendar Year 2024
- Topline Results Expected 1Q Calendar Year 2025
- Male Sexual Dysfunction: Development and Clinical Program
with Bremelanotide Co-Formulated with a PDE5i for the Treatment of
Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i
Monotherapy
- Pharmacokinetics Study Expected to Start 1Q Calendar Year
2025
- Patient Recruitment in Phase 3 Study Anticipated in 2H
Calendar Year 2025
- Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study
in Active UC Patients
- Interim Analysis Readout Expected in 4Q Calendar Year
2024
- Topline Results Anticipated 1Q Calendar Year 2025
- Potential Collaboration Discussions Ongoing
CRANBURY, N.J. ,
Sept. 9,
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 an update on its clinical programs, strategic priorities,
and anticipated milestones.
"We continue to execute on the clinical development front and
expect several key milestones from multiple programs over the next
twelve months," said Carl Spana,
Ph.D., President and Chief Executive Officer of Palatin. "Patient
dosing has commenced in our Phase 2 clinical study of an MC4R
agonist plus a GLP-1 in obese patients. Our clinical program
evaluating bremelanotide co-formulated with a PDE5i for the
treatment of ED in patients who do not respond to PDE5i monotherapy
is expected to begin in the first half of calendar year 2025. An
interim analysis readout on our Phase 2 clinical trial of PL8177 in
patients with UC is expected later this calendar year.
Additionally, as a result of a positive Type C meeting with the FDA
and agreement on PL9643 for DED Phase 3 trial protocols and
endpoints, we anticipate the initiation of pivotal clinical studies
MELODY-2 and MELODY-3 in the fourth quarter of this calendar
year."
Dr. Spana further commented, "We are focused on the continued
development of melanocortin receptor system treatments for obesity
and male sexual dysfunction. We are actively engaging in
discussions with potential partners and companies that have the
financial and operational resources to progress PL9643 for DED, our
other ocular programs, and our ulcerative colitis program, through
development, approval, and into commercialization.
Program Updates and Anticipated
Milestones
Ocular Programs (melanocortin receptor
agonists):
- Phase 3 PL9643 clinical program for the treatment of dry eye
disease (DED):
- Potential collaboration/funding discussions ongoing
- MELODY-2 & MELODY-3 Phase 3 pivotal clinical studies
- Concluded a positive Type C meeting with the FDA and
reached an agreement on sign and symptom endpoints on the remaining
two Phase 3 pivotal trial protocols
- Targeting 4Q calendar year 2024 to begin patient
enrollment
- Topline results anticipated 4Q calendar year 2025
- Potential NDA submission 1H calendar year 2026
- Successful Phase 3 MELODY-1 pivotal study successfully
completed
- Statistical significance (p<0.025) met for co-primary
symptom endpoint of pain
- Statistical significance (p,0.05) met for 7 of 11 secondary
symptom endpoints at the 12-week treatment period
- Statistical significance (p<0.05) met for rapid onset of
efficacy and multiple symptom endpoints, including the co-primary
pain endpoint at the 2-week treatment period and continued to
improve over the 12-week treatment period
- Statistical significance (p<0.05) met for multiple sign
endpoints, including 4 fluorescein staining endpoints at the
2-week treatment period
- Corneal fluorescein staining is used to measure corneal
epithelial damage and reductions in corneal fluorescein staining
with treatments like PL9643 indicate improvement in corneal
health
- Excellent safety and tolerability profile
Obesity Program:
- Phase 2 clinical study for the co-administration of
melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1)
in obese patients for the treatment of obesity:
- Initiated 2Q of calendar year 2024
- Patient dosing commenced 3Q calendar year 2024
- Topline results expected 1H calendar year 2025
- The study is designed to enroll up to 60 patients at four trial
sites in the United States with
the
- Primary endpoint of the trial to demonstrate the safety and
increased efficacy of co-administration of bremelanotide with
tirzepatide on reducing body weight
- Patients will be treated with tirzepatide-only for four
weeks, have eligibility confirmed, then randomized to one of four
treatment regimens
- Patients will undergo multiple assessments of safety and
efficacy to help profile the effectiveness of bremelanotide in
treating general obesity as a stand-alone treatment or in
conjunction with GLP-1/GIP therapy
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov via
the identifier NCT06565611
- Novel MC4R selective long-acting agonist:
- Initiation of investigational new drug (IND) enabling
activities expected 4Q of calendar year 2024
- Filing of IND anticipated 2H of calendar year 2025
Male Sexual Dysfunction Program:
- Initiated a development and clinical program for the evaluation
of bremelanotide co-formulated with PDE5 inhibitor (PDE5i), for the
treatment of erectile dysfunction (ED) in patients that do not
respond to PDE5i monotherapy:
- Pharmacokinetics study initiation expected to start 1Q of
calendar year 2025
- Patient recruitment in Phase 3 clinical study anticipated 2H
calendar year 2025
- Topline results targeted for 1H calendar year 2026
- Approximately 35% of men with ED have an inadequate response to
PDE5i treatments and represent a large underserved market
- Palatin previously conducted clinical trials showing the
synergistic effects of combining bremelanotide with a PDE5i as a
treatment for ED
Ulcerative Colitis Program (melanocortin receptor
agonist):
- Phase 2 PL8177 oral formulation for the treatment of ulcerative
colitis (UC):
- Potential collaboration discussions ongoing
- Interim analysis expected in 4Q calendar year 2024
- Topline results anticipated 1Q calendar year 2025
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov via
the identifier NCT05466890
Diabetic Nephropathy Program (melanocortin receptor
agonist):
- Phase 2 bremelanotide BREAKOUT study (BMT 701) in patients with
diabetic kidney disease:
- Topline results expected in the fourth quarter of calendar year
2024
- Additional trial information, including inclusion and exclusion
criteria, can be found at https://clinicaltrials.gov/ via the
identifier NCT05709444
Vyleesi®
(bremelanotide injection) / Hypoactive Sexual
Desire Disorder:
- Asset sale to Cosette Pharmaceuticals for up to $171 million closed in December 2023:
- $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
- Palatin retained rights and use of bremelanotide for obesity
and male erectile dysfunction indications
About Melanocortin Receptor Agonists
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. 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 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 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/palatin-provides-update-on-clinical-programs-strategic-priorities-and-anticipated-milestones-302241614.html
SOURCE Palatin Technologies, Inc.