Our Pipeline

DEMONSTRATED LEADER IN THE DISCOVERY AND DEVELOPMENT OF MELANOCORTIN AGONIST TREATMENTS

We have only just started tapping into the utility of melanocortin pathways in treating patients after establishing ourselves with Vyleesi® (bremelanotide injection) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, as the first FDA-approved melanocortin agent. We are focused on amplifying its commercial platform in North America, supporting commercialization partners globally, and subsequently re-licensing to committed partners in the U.S. and worldwide.

Our development arm builds on our proven success in bringing a melanocortin therapeutic from the lab to market by using our experience to propel our programs in ocular and autoimmune diseases through our clinical pipeline.

Pipeline Development Programs

Melanocortin Receptor Programs​
Melanocortin Receptor Programs
Pre-
clinical
Phase 1
Phase 2
Phase 3
NDA
FDA
Approval
Status/Next Steps

PL9643 MCr Agonist

Dry Eye Disease
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

Phase 3 MELODY-1
Last patient completed study

Phase 3 data expected 1Q2024

PL9654 MCr Agonist

Retinal diseases
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

IVT delivery

Topical delivery

PL8177 Oral MCR1 Agonist

Ulcerative colitis (UC)
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

Phase 2 enrolling

Interim data expected 2Q2024

Final data 2H2024

MCr Agonist

Diabetic Nephropathy
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

Phase 2 Open label

Enrollment completed

Final data expected 2Q2024

Bremelanotide + PDE5i*

PDE5i failures
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

Phase 2 PK dosing co-administration study

Targeting FPI-1Q2024    Data 2H2024

Co-formulation IND 2H2024

Bremelanotide*

Obesity GLP1 adjunct therapy
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval
Phase 2 GLP1 patients gap days Targeting FPI-1Q2024    Data 2H2024

Novel MCR4 Agonist*

Multiple obesity indications
Pre-clinical
Phase 1
Phase 2
Phase 3
NDA
FDA Approval

Daily and extended dosing formats

Peptide therapeutic IND filing 1H2025

Oral small molecule lead ID 1H2025

* These programs are planned but dependent on funding.

Commercial Product

Vyleesi® (bremelanotide)

Hypoactive Sexual Desire Disorder
Asset Sale for FSD Rights to Cosette December 2023
Up to $159 million in potential sales milestones and $10.5 million in potential regulatory milestones

PIONEERING A NEW TREATMENT PARADIGM
FOR OCULAR DISEASES

The need for innovative treatments for ocular indications remains unmet. Specifically, dry eye disease (DED) is a chronic, painful, and debilitating inflammatory eye condition that causes irritation, redness, discharge, and blurred vision. Over 20 million people in the U.S. are estimated to be living with DED.

Palatin is developing a truly novel class of drugs that selectively bind to melanocortin receptors (MCR), with both MCR1 and pan-agonists, to directly activate natural pathways that resolve disease inflammation in the eye. Melanocortin agonists provide potential advantages over current options to better meet the needs of patients and clinicians by directly addressing harmful inflammation, resulting in rapid, global improvement of affected tissues.

Our PL9643 ophthalmic solution (topical eye drops) is currently undergoing late-stage Phase 3 clinical development. Our Phase 2 study demonstrated improvements in both the signs and symptoms of DED after just 2 weeks of treatment, with no safety signals and excellent tolerability.

Additional melanocortin receptor agonists are under investigation to resolve other inflammatory ocular diseases, including non-infectious uveitis, diabetic retinopathy, and diabetic macular edema.

ADVANCING A NOVEL APPROACH TO TREATING AUTOIMMUNE DISEASES

There’s incredible potential to address the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that increase the risk of complications. The presence of high MCR1 levels in the gut makes ulcerative colitis (UC) a target for melanocortin receptor agonist therapy. This will benefit the nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon.

Our oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with our potent, selective compound. This delayed-release, oral formulation is designed to deliver drug to diseased bowel, maximizing local treatment while avoiding systemic adverse effects.

Two Phase 1 studies have produced promising results. The first demonstrated significant safety and tolerability of PL8177; the second highlighted the value of an oral, delayed-release polymer formulation that can achieve local release without systemic absorption. PL8177 has advanced and is now being investigated in a Phase 2 clinical trial.

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