Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

• 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.

SOURCE Palatin Technologies, Inc.