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Data Anticipated Q4 2020
CRANBURY, N.J., July 8, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced reinitiation of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease (DED).
After pausing patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic, Palatin has commenced patient recruitment in its PL9643 Phase 2 clinical study in subjects with dry eye disease. Patient enrollment is currently expected to be complete within the next 30-45 days, with data readout targeted for the fourth quarter of calendar year 2020.
"We are very happy to resume patient recruitment in this Phase 2 study of PL9643 exploring treatment of both the signs of eye damage and the physical symptoms experienced by patients with dry eye disease," commented Carl Spana, Ph.D., President and CEO of Palatin.
This Phase 2 study is a multi-center, randomized double-masked, placebo-controlled study evaluating the safety and efficacy of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye disease. The study is designed to enroll up to 150 participants at three sites in the US. Patients will be randomized in a 1:1 ratio into two arms, PL9643 or placebo, and will undergo 12-weeks of treatment. For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov
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 30 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 Technologies, Inc.
Palatin Technologies, Inc. is a specialized 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 in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, 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, transfer of marketing and sale of Vyleesi in North America to another pharmaceutical company, 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.