Palatin Announces Presentation at the Eyecelerator@ASCRS Conference
Palatin Technologies (PTN) announced a presentation by CEO Carl Spana at the Eyecelerator@ASCRS Conference in Las Vegas, discussing the role of melanocortins in reducing inflammation and presenting data from a Phase 2 study of PL9643 for dry eye disease (DED). The company is set to initiate a Phase 3 clinical trial in late 2021, with a potential NDA submission in late 2023. Notably, PL9643 demonstrated statistically significant improvements in patient symptomatology and showed excellent ocular tolerability in the Phase 2 study.
- PL9643 showed statistically significant improvement in dry eye disease during Phase 2 study.
- Phase 3 clinical trial for PL9643 expected to start in Q4 2021.
- No safety signals identified; excellent ocular tolerability was reported.
- The NDA submission for PL9643 is not expected until the second half of 2023, indicating a delay in market entry.
CRANBURY, N.J., July 22, 2021 /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 that Carl Spana, PhD, President and CEO of Palatin, presented today at the Eyecelerator@ASCRS Conference in Las Vegas, NV. The presentation is one of several Company Showcases in the general session titled: "Dry Eye: The Need for Innovation." The topics of the presentation were melanocortins' role in resolving inflammation and presentation from a Phase 2 study with Palatin's compound PL9643 for dry eye disease (DED) and included information about Palatin's research program with melanocortins in retinal disease.
Eyecelerator is a partnership between the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS). Its mission is to connect entrepreneurs, investors, companies, and physicians to advance ophthalmic innovation through live conferences, virtual programming, and a next-generation networking platform.
Palatin is on track to initiate a Phase 3 clinical study with PL9643 in patients for the treatment of dry eye disease during the fourth quarter of calendar year 2021, with data readout expected in the second half of calendar year 2022. If the program progresses as planned, an NDA submission is targeted for the second half of calendar year 2023.
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.
American Academy of Ophthalmology
The Academy is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, it protects sight and empowers lives by setting the standards for ophthalmic education and advocating for patients and the public. The Academy innovates to advance the profession and to ensure the delivery of the highest-quality eye care. Through its EyeSmart® articles on AAO.org, the Academy provides the public with the most trusted information about eye health. For more information, visit aao.org.
ASCRS (American Society of Cataract and Refractive Surgery)
ASCRS is an international educational society with nearly 8,000 ophthalmic surgeons at every career stage. Its mission is to empower anterior segment surgeons to improve the vision, outcomes, and quality of life for their patients through innovative approaches to education, advocacy, and philanthropy. For more information, visit ascrs.org.
About Melanocortins and Inflammation
The melanocortin receptor ("MCr") system has effects on food intake, metabolism, sexual function, inflammation, and immune system responses. 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 significant pharmacological effects.
Many tissues and immune cells located in the eye express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About Dry Eye Disease (DED)
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease 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 dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.
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, such as statements about clinical trial plans and potential results for PL9643, 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 for events that occur after the date of this press release.
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SOURCE Palatin Technologies, Inc.
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