Palatin Reports Positive Interim Analysis in Pivotal Phase 3 Study of PL9643 in Dry Eye Patients

  • Independent data monitoring board recommends continuation of study with target sample size of up to 350 patients – up to 230 additional patients to be recruited
  • No security issues identified
  • First results currently expected for the second quarter of the 2023 calendar

CRANBURY, NJ, August 16, 2022 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing innovative drugs based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced the results of a planned study interim analysis of the pivotal phase 3 study of PL9643 (MELODY-1) in patients with dry eye disease (DED). The interim analysis included an assessment and review by the independent Data Monitoring Committee (DMC) of the efficacy and safety of the first 120 patients who completed treatment. Based on their review, the DMC recommended that the study continue with a study sample size goal of up to 350 patients. No safety issues were identified by the DMC.

The main objective of the DMC was to provide a recommendation on the final sample size based on an interim assessment using a conditional power modeling approach. The DMC had the option of recommending a final sample size of up to 600 patients. The DMC has performed its assessment on the first 120 patients to complete the study and, based on their recommendation, Palatin plans to enroll up to 230 additional patients in the study for a final sample of 350 patients. The first results are expected in the second quarter of calendar year 2023.

“We are very encouraged by the DMC’s recommendation to continue to enroll patients in this ongoing trial. Emerging data, including safety and ocular tolerability, indicate that PL9643 could be a potentially safe and effective treatment for patients with DED,” said Carl Spana, Ph.D., President and CEO of Palatine. “Based on the trial results to date, we believe that PL9643, with its differentiating factors, could provide a fast-acting and well-tolerated treatment option for the millions of patients suffering from DED, and we look forward to to present the first results of this Phase 3 trial in the second quarter of calendar year 2023.”

The pivotal Phase 3 MELODY-1 clinical study is a multicenter, randomized, double-blind, vehicle-controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 Ophthalmic Solution, versus vehicle in patients with moderate to severe DED. The study design is based on positive Phase 2 results of PL9643 for the treatment of DED and an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), reaching agreement on all key elements of a Phase 3 Clinical Program.

About Dry Eye Disease (DED)
Dry eye is a common inflammatory condition which, if left untreated, can become extremely painful and lead to permanent corneal and vision damage. DED affects the cornea and conjunctiva of the eye, causing irritation, redness, pain, and blurred vision. It is estimated to affect more than 20 million people in United States. The disease is characterized by insufficient moisture and lubrication of the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, reduced quality of life and, in severe cases, permanent visual impairment. Existing therapy for DED is generally considered inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.

About melanocortin receptor agonists and inflammation
The melanocortin (“MCr”) receptor 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 the 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 in the eye (and other places, e.g. gut and kidney) express melanocortin receptors, allowing us to directly activate natural pathways to resolve inflammation of the disease.

About the Palatine
Palatin is a biopharmaceutical company developing first-in-class drugs based on molecules that modulate the activity of melanocortin and natriuretic peptide receptor systems, with targeted and receptor-specific product candidates for the treatment of diseases of medical need. unsatisfied and significant commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their market potential. For more information about Palatin, please visit the Palatin 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 Palatin’s future expectations, 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 such term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that these forward-looking statements be subject to the exemption rules thus created. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to differ materially from its historical results or from any results expressed or implied by these forward-looking statements. Palatin’s actual results may differ materially from those referred to in the forward-looking statements for reasons including, but not limited to, clinical trial results, regulatory actions by the FDA and other regulatory authorities, and the necessity regulatory approvals, Palatin’s ability to fund the development of its technology and establish and complete clinical trials, the time and cost required to complete clinical trials and submit applications for regulatory approval, the products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, the 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.

SOURCEPalatin Technologies, Inc.

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