Palatin and FDA Reach Agreement on Path to NDA Submission, including Trial Design, Endpoints, Interim Assessment, and Patient Population
On Track to Initiate Phase 3 Study Calendar Q4 2021 with Data Expected Calendar 2H 2022
Jun 29, 2021, 07:30 ET
CRANBURY, N.J., June 29, 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 the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for PL9643 for the treatment of dry eye disease (DED).
The EOP2 meeting scope included all aspects of PL9643’s development plan, with the FDA and Palatin reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, a potential second Phase 3 study and long-term safety study were discussed to support a New Drug Application (NDA). Palatin remains on track to initiate the Phase 3 program in DED patients 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.
“As a practicing ophthalmologist, I am encouraged by the data to date on the PL9643 program, which offers much needed optimism for an effective treatment of dry eye without tolerability issues,” said Michael Raizman, M.D., Chief Medical Officer of Palatin. “I look forward to further demonstrations of PL9643’s potential to transform the topical treatment of DED for the millions of people suffering from the disease.”
“We now have clarity on the registrational path required to demonstrate the safety and efficacy of PL9643, having reached agreement with FDA on all key elements of PL9643’s pivotal phase 3 program for DED,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “This is an important corporate milestone, as we now have a second melanocortin agonist in phase 3 development, which we believe validates our strategy which focuses our efforts on the development of melanocortin based therapeutics for inflammatory and autoimmune 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.
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.
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.
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.
SOURCE Palatin Technologies, Inc.