Palatin to Present at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference

Rhea-AI Summary

Palatin Technologies (NYSE American: PTN) announced presentations at the ARVO 2022 Annual Conference in Denver from May 1-4. The posters highlight data from a Phase 2 study of PL9643 for treating dry eye disease (DED), revealing statistically significant improvements in symptoms after 2 and 12 weeks of dosing, with no safety concerns. A Phase 3 study (MELODY-1) is currently enrolling participants, with topline data expected in Q4 2022 and a potential NDA submission in H1 2024. These efforts underline Palatin's commitment to developing innovative therapies for significant unmet needs.

Posters highlight Palatin's ocular research and PL9643 Phase 2 clinical data

CRANBURY, N.J., May 2, 2022 /PRNewswire/ -- Palatin Technologies, Inc. ("Palatin") (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, today announced two poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Conference being held May 1-4 in Denver.

The posters reflect data on Palatin's novel ocular research program and from a Phase 2 study with Palatin's compound PL9643 for dry eye disease (DED). 

Poster details:
Session: Dry Eye, Clinical
Posterboard #: A0288
Session Date: May 2, 2022
Session Time: 2:30-4:30 pm EDT
Poster Title: Efficacy and safety of the melanocortin agonist PL9643 in a phase 2 study of subjects with dry eye disease

Session: Biochemistry and Molecular Mechanisms of Diabetic Retinopathy
Posterboard #: A0047
Session Date: May 4, 2022
Session Time: 12:00-2:00pm EDT
Poster Title: Efficacy and impact of the melanocortin receptor agonists PL8177 and PL9654 in an STZ-rat model of diabetic retinopathy

The posters will be available on Palatin's website at: www.palatin.com.

Palatin's innovative and comprehensive research regarding the mechanism of action and efficacy of melanocortins in tissues and animals continues to produce consistent and robust data supporting melanocortins' role in the process of resolving inflammation and information supporting further development of Palatin's compounds for the treatment of inflammatory conditions.

PL9643 is a novel melanocortin agonist, delivered to the eye topically via eyedrops. Palatin previously announced positive results in its Phase 2 study of PL9643 for the treatment of DED. Statistically significant improvement in multiple signs and symptoms was achieved in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability.

Palatin's Phase 3 clinical study (MELODY-1) with PL9643 is currently enrolling patients, with topline data currently expected during the fourth quarter of calendar year 2022. If the program progresses as planned, an NDA submission is targeted for the first half of calendar year 2024.

About The Association for Research in Vision and Ophthalmology (ARVO)

ARVO is the largest and most respected eye and vision research organization in the world. Their members include nearly 11,000 researchers from over 75 countries.  The mission of ARVO is to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders. (arvo.org)

About Dry Eye Disease (DED)

DED is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.

About Melanocortin Receptor Agonists and Inflammation

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 and natriuretic peptide 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.

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 market potential of Vyleesi and other Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, 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 for events that occur after the date of this press release.

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SOURCE Palatin Technologies, Inc.

FAQ

What are the key findings from Palatin's PL9643 Phase 2 study presented at ARVO 2022?

The Phase 2 study of PL9643 showed statistically significant improvements in symptoms of dry eye disease after 2 and 12 weeks, with no safety concerns.

When is the Phase 3 study MELODY-1 for PL9643 expected to provide topline data?

Topline data from the Phase 3 study MELODY-1 is anticipated in the fourth quarter of 2022.

What is the potential NDA submission timeline for PL9643?

If all goes as planned, an NDA submission for PL9643 is targeted for the first half of 2024.

What is the significance of the ARVO conference for Palatin Technologies?

The ARVO conference is significant for Palatin as it showcases their ocular research and clinical trials, highlighting advancements in eye care.

Where can I find more information about Palatin's ocular research presentations?

More information about Palatin's ocular research presentations can be found on their website at www.palatin.com.