Following a successful Phase 2 study, a Phase 2/3 clinical trial for the compound is currently planned for mid-2021.
Palatin Technologies Inc. has announced the filing of an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides.
The specialized biopharmaceutical company reported positive results in its Phase 2 study of PL9643 for the treatment of Dry Eye Disease (DED).
According to the company, detailed study results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 virtual annual meeting.
In December, the company noted that 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.
At that time, Carl Spana, PhD, president and CEO of Palatin, said researchers were pleased with the results of the Phase II study.
“This was our first study evaluating a melanocortin agonist in an ocular disease and we are pleased that the key goals of this study were met, which was providing significant clinical evidence of efficacy, safety, and tolerability in a meaningful patient population – patients suffering from moderate to severe DED,” he said. “Importantly, we have a clear development and regulatory path forward. With approximately 20 million adults in the United States currently suffering from DED, the majority being moderate to severe patients, and up to 50% discontinuing treatment due to slow onset, lack of efficacy or intolerance, PL9643’s potentially quick onset of efficacy and excellent tolerability profile are differentiating factors to current approved therapies.”
The Phase 2/3 clinical trial with PL9643 for the treatment of DED is currently planned for mid-2021.
The company noted in a statement that the PCT application for PL9643 establishes the base for the presumptive patent term, and if a patent is granted which claims priority to this application, could provide patent protection for PL9643, and any product in which PL9643 is the active pharmaceutical ingredient, out to 2041, excluding any additional term for patent adjustment or patent term extension.
Palatin said in the statement it believes that the structure of PL9643 “is novel and inventive.” The International Search Authority will conduct a search and issue its written opinion on PL9643 and the related family of melanocortin agonist peptides, which will provide additional information on patentability of PL9643 and the related family.
Kenneth Kenyon, MD, principal investigator for the Phase II study and a cornea specialist at New England Eye Center and Professor of Ophthalmology, Tufts University School of Medicine, said in the December news release that the work, utilizing the melanocortin pathway is proving to be an excitingly novel departure from all other dry eye therapeutic strategies.
“The demonstrated consistency of improved outcomes across multiple sign and symptom time points is most impressive,: he said in the statement. “Significant improvement in both corneal and conjunctival staining is highly relevant, as it affects both vision and irritative symptoms, especially so in these more advanced dry eye patients. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy.”
The company said in the statement that it anticipates filing patent applications in the United States, Europe and a number of additional regions an
d countries throughout the world.