Palatin Technologies, Inc. Announces First-in-Human Study Results of Subcutaneous Administration of PL-8177, An Investigational Melanocortin Receptor 1 Agonist
CRANBURY, N.J., Nov. 8, 2018 /PRNewswire/ -- Palatin Technologies Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced Phase 1, first-in-human results of a single and multiple ascending-dose study of PL-8177, a patented melanocortin receptor 1 agonist with the potential application of treating ulcerative colitis and other inflammatory diseases. The data of subcutaneous administration of PL-8177 demonstrated favorable pharmacokinetics and pharmacodynamic properties and no safety or tolerability concerns were reported.
The objective of the Phase 1 study was to assess the safety and tolerability of PL-8177 and evaluate the pharmacokinetics and systemic exposure following both a single-ascending dose (SAD) and multiple-ascending doses (MAD) of PL-8177.
"Meeting all safety and study objectives of subcutaneous administration of PL-8177 is an important first step in the development of our second melanocortin peptide," said Dr. Carl Spana, CEO of Palatin Technologies. "We are very excited to continue development of PL-8177 and explore additional treatment opportunities. This demonstrates our expertise in and our commitment to the development of a robust pipeline of novel peptides targeting the melanocortin system. Our expansive library of MC1r peptides has the potential to treat a wide variety of inflammatory diseases, and we believe will continue to show positive results with further development."
The study enrolled 36 subjects who participated in the SAD stage and 20 subjects were enrolled and participated in the MAD stage of the randomized, double-blind and placebo-controlled Phase 1 study. All subjects in the SAD and MAD cohorts completed dosing. Overall, PL-8177 was well-tolerated when administered as a single and multiple ascending dose regimen, and a distinct pharmacokinetic profile was established in both the SAD and MAD parts of the study. No serious adverse events were reported in the SAD or MAD parts of the study.
PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases. Evolving research suggests that the MC1r system plays an important role in anti-inflammatory responses and immunoregulation, including resolution of innate pro-inflammatory immune responses.
Data from a separate clinical study investigating an oral formulation of PL-8177 is currently expected by the end of 2018.
About Ulcerative Colitis
About Palatin Technologies, Inc.
View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-announces-first-in-human-study-results-of-subcutaneous-administration-of-pl-8177-an-investigational-melanocortin-receptor-1-agonist-300746297.html
SOURCE Palatin Technologies, Inc.
Company Codes: AMEX:PTN