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 MilestonesOcular 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

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