Palatin Presents Promising Preclinical Data on Melanocortin Agonists for Retinopathy at ARVO 2025

Rhea-AI Summary

Palatin Technologies (OTC PINK: PTNT) presented new preclinical data for its melanocortin agonists PL9654 and PL9655 at ARVO 2025, demonstrating promising results for treating diabetic retinopathy (DR). The compounds showed effectiveness in resolving inflammation, stabilizing blood-retinal barriers, reducing VEGF signaling, and protecting retinal ganglion cells. Key findings include vision preservation, inflammation control, retinal protection, and anti-angiogenic properties. Both compounds demonstrated efficacy through multiple administration routes, including topical delivery. This research is particularly significant as DR affects up to 80% of long-term diabetes patients, with CDC projecting U.S. cases to triple from 5.5 million in 2025 to 16 million by 2050. The melanocortin receptor system's role in regulating inflammation and tissue repair makes these compounds promising candidates for treating ocular diseases.

Positive

• Both PL9654 and PL9655 demonstrated efficacy in multiple preclinical models
• Compounds showed multiple therapeutic benefits: inflammation control, vision preservation, and retinal protection
• Flexibility in administration routes, including topical delivery, enabling earlier intervention
• Targeting a large market with DR affecting up to 80% of long-term diabetes patients
• Significant market growth potential with CDC projecting U.S. cases to triple by 2050

Negative

• Still in preclinical stage, requiring extensive clinical trials before potential approval
• Results limited to preliminary animal studies, human efficacy yet to be demonstrated
• Potential competition from existing DR treatments in the market

Insights

Biotech Research Analyst

Palatin's melanocortin agonists show promising preclinical results for diabetic retinopathy with multiple administration routes and mechanisms of action.

Palatin's presentation at ARVO 2025 represents an important milestone in their development of melanocortin receptor agonists PL9654 and PL9655 for diabetic retinopathy (DR). The preclinical data demonstrates multiple beneficial effects that collectively address the key pathological mechanisms involved in DR progression.

What makes these compounds particularly interesting is their multi-pathway approach. Rather than targeting a single mechanism like current anti-VEGF therapies, these agonists work through several complementary pathways: resolving inflammation, stabilizing the blood-retinal barrier, reducing VEGF signaling, and protecting retinal ganglion cells. This comprehensive approach could potentially provide superior efficacy compared to single-target treatments.

The topical administration option represents a significant potential advantage over current DR treatments, which typically require intravitreal injections. This less invasive delivery method could enable earlier intervention in the disease process, potentially preserving vision before significant damage occurs. The gene set enrichment analysis showing downregulation of immune-related pathways provides a mechanistic explanation for the observed effects.

While these results are promising, it's important to emphasize that this remains early-stage research. The data comes from preclinical models, and many promising compounds fail during clinical development. No timeline for potential clinical trials was mentioned, suggesting commercialization remains years away. Additionally, the company will need to demonstrate these effects translate to humans and establish appropriate dosing, safety profiles, and meaningful clinical outcomes.

The market opportunity is substantial, with diabetic retinopathy affecting millions of patients and prevalence expected to increase significantly in coming decades, potentially tripling by 2050 according to CDC projections cited in the release.

Findings highlight PL9654 and PL9655's potential to treat diabetic retinopathy through inflammation resolution, vascular stabilization, and neuroprotection

• PL9654 and PL9655 down-regulate inflammatory pathways, suppress angiogenesis, and preserve retinal structure and function
• Topical and systemic administration options enable potential for earlier intervention than current therapies
• Results support the continued development of PL9654 and PL9655 for the treatment of diabetic retinopathy (DR)

CRANBURY, N.J., May 9, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (OTC PINK: PTNT), a biopharmaceutical company advancing innovative treatments targeting the melanocortin receptor system, today announced new preclinical data on its melanocortin agonists PL9654 and PL9655 at the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

The findings demonstrate the agents' ability to resolve inflammation, stabilize the blood-retinal barrier, reduce VEGF signaling, and protect retinal ganglion cells, key drivers of vision loss in diabetic retinopathy. Notably, both compounds showed efficacy across multiple models and routes of administration, including topical delivery.

The poster, titled "Activating the melanocortin system resolves inflammation, reduces VEGF signaling in diabetic retinopathy (DR), and provides retinal ganglion cell (RGC) protection," was presented by Paul Kayne, Ph.D., Vice President, Biological Sciences at Palatin. The full poster is available at www.palatin.com.

"Palatin's melanocortin research data are unparalleled in demonstrating multi-pathway inflammation resolution," said Carl Spana, Ph.D., President and CEO of Palatin. "The ability to modulate immune response, suppress angiogenesis, and preserve neural integrity, especially via topical administration, could transform treatment for retinal diseases like diabetic retinopathy."

Key Findings:

• Vision preservation: PL9654 and PL9655 maintained contrast vision and showed significant efficacy compared to vehicle.
• Inflammation control: Gene set enrichment analysis revealed downregulation of immune-related pathways in microglia and Müller glial cells for PL9654 and PL9655 compared to vehicle.
• Retinal protection: PL9654 reduced ischemia-reperfusion-induced retinal damage (as measured by histological scoring), similar to the melanocortin peptide α-MSH.
• Cell integrity: Microglia and Müller glial cell levels in treated animals mirrored those in healthy controls.
• Neuroregeneration: Topical PL9655 treatment increased rod photoreceptor levels relative to vehicle.
• Anti-angiogenesis: PL9654 significantly inhibited choroidal neovascularization and fibrosis (P<0.01). PL9655 topical treatment also showed an increase in rods compared with vehicle.

About Diabetic Retinopathy (DR)
DR is a progressive, diabetes-related complication that damages blood vessels in the retina, leading to vision loss and blindness. It is one of the leading causes of vision impairment among adults aged 20 to 64.

• DR affects up to 80% of people with diabetes for 20 years or more.
• The CDC projects DR prevalence in the U.S. will triple from 5.5 million in 2025 to 16 million by 2050.
• DRCR.net estimates 11.3 million people in the U.S. will be affected by 2030, rising to 14.6 million by 2050, with 28 million at risk for vision-threatening DR globally.

About Melanocortin Receptor System
The melanocortin receptor (MCR) system plays a critical role in regulating inflammation, immune response, and tissue repair. MCR agonists have shown promise in restoring tissue homeostasis in ocular, gastrointestinal, and renal diseases. By activating natural resolution pathways, PL9588 and other melanocortin agonists represent a new class of anti-inflammatory, neuroprotective therapeutics.

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 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, 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.

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SOURCE Palatin Technologies, Inc.

FAQ

What are the key findings of Palatin's PL9654 and PL9655 preclinical trials for diabetic retinopathy?

The preclinical trials showed that PL9654 and PL9655 maintained contrast vision, controlled inflammation, protected retinal cells, and demonstrated anti-angiogenic properties. Both compounds were effective through multiple administration routes, including topical delivery.

How does PTN's melanocortin receptor system work in treating diabetic retinopathy?

The melanocortin receptor system regulates inflammation, immune response, and tissue repair. PTN's compounds activate natural resolution pathways to resolve inflammation, stabilize blood-retinal barriers, reduce VEGF signaling, and protect retinal ganglion cells.

What is the market potential for Palatin's diabetic retinopathy treatment?

The market potential is significant, as diabetic retinopathy affects up to 80% of long-term diabetes patients. CDC projects U.S. cases to increase from 5.5 million in 2025 to 16 million by 2050.

What advantages do PL9654 and PL9655 offer over current diabetic retinopathy treatments?

The compounds offer multiple administration routes, including topical delivery, enabling earlier intervention. They provide comprehensive benefits including inflammation resolution, vascular stabilization, and neuroprotection through a single treatment approach.

When did Palatin present their diabetic retinopathy treatment data at ARVO 2025?

Palatin presented their preclinical data on melanocortin agonists PL9654 and PL9655 at the ARVO Annual Meeting on May 9, 2025.