Independent Data Monitoring Committee Recommends Continuing Study with Sample Size Target of up to 350 Patients – up to Additional 230 Patients to be Enrolled
No Safety Concerns Identified
Topline Results Currently Expected Second Quarter Calendar 2023
CRANBURY, N.J., Aug. 16, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced the results of a planned interim analysis of the Phase 3 pivotal 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 had completed treatment. Based on their review, the DMC recommended the study continue with a study sample size target of up to 350 patients. No safety concerns were identified by the DMC.
The DMC's primary objective 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 to recommend a final sample size of up to 600 patients. The DMC performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients. Topline results are expected in the second quarter of calendar 2023.
"We are highly encouraged by the DMC's recommendation to continue enrolling patients in this ongoing trial. The emerging data, including the 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 Palatin. "Based on trial results to date, we believe 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 presenting topline results of this Phase 3 trial in the second quarter of calendar 2023."
The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to 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 pivotal Phase 3 clinical program.
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. 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.
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 and follow Palatin on Twitter at @PalatinTech.
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.