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By Kyle Anthony, Benzinga

Palatin Technologies (AMEX: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, received the first FDA approval for a melanocortin agent, for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with its product, Vyleesi® (bremelanotide injection) – and it has big plans for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra®, cialis®) monotherapy

The melanocortin system is a group of hormones, receptors and other molecules in the body that regulate various physiological processes, including skin pigmentation, appetite, energy balance and inflammation. For Palatin Technologies, the melanocortin system has been a source of innovation. The firm leverages its knowledge of the melanocortin system to design therapeutics that directly engage one of the body’s natural pathways to resolve harmful inflammation, providing a novel approach that allows affected tissue time to heal.

The Mission Of Palatin Technologies

Founded in 1986 by Dr. Carl Spana and other scientists with the initial aim of developing proprietary technologies and drug candidates for large markets with unmet needs, including cardiovascular disease and cancer, the firm has undergone a series of changes over the years. In the early 2000s, Palatin began focusing on the melanocortin system, particularly developing drugs that target melanocortin receptors. The company’s mission is to leverage its unique insight and expertise in the industry and the melanocortin system to develop groundbreaking therapeutics for inflammatory and autoimmune diseases, focusing on ocular conditions, plus obesity and sexual dysfunctions.

Maximizing The Capabilities Of The Melanocortin System

The melanocortin system is mediated by a family of five related receptors that are essential to the body’s control of inflammation, immune response, metabolism, steroid hormone production and sexual function. As mentioned previously, Palatin Technologies’ current focus is on the design and development of receptor-selective melanocortin agonists for inflammation and autoimmune conditions, with an emphasis on ocular diseases, plus obesity and sexual dysfunctions. Palatin Technologies’ therapeutics work by activating endogenous melanocortin pathways to resolve damaging inflammation and allow affected tissues time to heal. Research has shown melanocortin agonists can prevent and reverse intestinal and ocular inflammation in animal models.

Current ocular drugs can be limited by drawbacks such as inadequate efficacy, high discontinuation rates and delayed onset of action. These challenges result in a less-than-ideal treatment experience, causing frustration and driving the need for more effective solutions. Melanocortin receptors, which are found on the surface of various cells in the eye and within immune cells in ocular tissue, represent a promising target for melanocortin agonists to offer relief and healing for individuals suffering from ocular diseases.

For inflammation and autoimmune diseases, current treatments – including steroids, immune modulators and biologics – largely work by broadly suppressing the immune response. However, these methods can weaken the body's overall immune function, leading to unwanted side effects and raising safety concerns. Melanocortin agonists offer the potential to resolve inflammation without these adverse effects and safety issues associated with immunosuppressants.

Palatin Technologies: Success And Product Pipeline

Though Vyleesi was Palatin Technologies' first commercial product, the company recently announced several program advancements:

• Patient dosing has started for the clinical study entitled: BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity

  • Topline Results Expected Q1 Calendar Year 2025

• FDA Confirms Acceptability of Palatin’s Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED)

  • MELODY-2 & MELODY-3 Phase 3 Clinical Trials Targeted To Start Later This Calendar Year

  • Topline Results Expected Q4 Calendar Year 2025

Treating Eye Related Diseases

As referenced previously, Palatin is exploring using melanocortin agonists for age-related eye diseases. As detailed in the company’s corporate presentation, diseases such as dry eye disease, glaucoma and retinopathies are sizable target markets. Dry eye disease (DED) or keratoconjunctivitis is a multifactorial disorder of the tears and ocular surface. Symptoms include dryness, irritation, redness, discharge and blurred vision. Inflammation plays a prominent role in the development and amplification of the signs and symptoms of DED.

According to research compiled by the company, the global market size for DED is estimated to be worth $7.0 billion in 2024, growing to $12.3 billion by 2032. Earlier this year, Palatin announced the phase 3 clinical results for its PL9643 melanocortin agonist treatment of DED. Regarding the findings, Carl Spana, Ph.D., President and CEO of Palatin, stated, “We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign and symptom endpoints.”

PL9643 represents an opportunity to bring relief to dry eye disease sufferers. According to Palatin, while DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment with an excellent safety and tolerability profile.

There is a sizable market opportunity for the other previously mentioned eye diseases: Palatin’s research states that the 2030 global market estimate for glaucoma is $11.52 billion, and the 2027 global market estimate for retinopathies is $27 billion. Palatin has ongoing melanocortin receptor programs for each disease to explore treatment methods.

Treating Autoimmune Diseases

There is also a growing opportunity to treat the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that potentially increase the risk of complications. Palatin Technologies, with an ongoing phase 2 clinical trial, is exploring how its treatments can tackle ulcerative colitis (UC), which the company says could benefit nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon. Palatin’s research states that the global ulcerative colitis market was estimated to be worth $5.5 billion in 2021 and is projected to be worth $8 billion by 2026.

Palatin’s oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with its potent, selective compound. Palatin reports that two phase 1 studies have produced promising results – the first demonstrated the significant safety and tolerability of PL8177, while 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.

Treating Obesity

Obesity represents a rising worldwide public health concern. Obesity is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, coronary heart disease, stroke and certain cancers. Obesity is associated with increased healthcare resource use and high economic burden. Safe and effective obesity treatments therefore remain a critical unmet need. In the United States, about 42% of adults live with obesity, and one out of five teens between the ages of 12-19 live with obesity, according to data compiled by Palatin.

“The growth of GLP-1 agonists to treat obesity has been incredible and highly effective in the short run, but data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year, said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “This often results in a rebound effect with patients gaining back significant weight. Our research coupled with emerging clinical data indicates that combining an MCR4 agonist with incretin therapeutics like tirzepatide may result in synergistic effects on weight loss allowing for increased weight loss at lower and better-tolerated doses.”

Sexual Dysfunction Product Expansion And Product Development Milestones

The success of Vyleesi, which was sold to Cosette Pharmaceuticals in December 2023 for $12 million upfront and up to $159 million in sales milestones, has established a precedent for success in the sexual dysfunction category for Palatin Technologies. Presently, the firm is looking to build on this success and is exploring a product for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i (viagra®, cialis®) monotherapy. According to Palatin, over 30 million men in the U.S. suffer from ED, with approximately 35% of them being inadequately served by existing treatment options. Palatin believes that their MCR4 agonists can be a safe and effective treatment therapy for ED.

Across Palatin’s product roadmap, several milestones are slated to occur in the latter half of 2024 or the first half of 2025. Regarding the second half of calendar year 2024, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 will initiate enrollment (patient dosing has commenced), Melody-2 and Melody-3 phase 3 clinical trials for the treatment of DED will begin, and the phase 2 proof-of-concept interim data for PL8177 for ulcerative colitis is expected to readout.

Regarding the first half of calendar year 2025, the company’s phase 2 obesity trial of an MCR4 agonist + GLP-1 topline results are expected, and the pharmacokinetics study for the 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 will start.

A Vision For The Future For Millions Of Patients

Overall, Palatin Technologies is actively expanding its clinical programs and progressing toward potential new therapies for patients with limited or ineffective treatment options. Melanocortin pathway therapies represent a promising and versatile approach to treating various conditions, with ongoing research and development expanding their potential applications. Palatin Technologies is at the forefront of this treatment approach, potentially helping reshape the medical landscape.

For more information about Palatin Technologies, visit its website.

Featured photo by Louis Reed on Unsplash.

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