In its Phase l clinical trial, Palatin Technologies has begun administering PL-8177 to patients to determine its safety and tolerability for the treatment of ulcerative colitis and other inflammatory bowel diseases.

Ulcerative colitis is a long-term disease of the large intestine characterized by ulcerations and inflammation that can lead to significant abdominal pain, persistent diarrhea, and decreased appetite.

A randomised, double-blind, placebo-controlled, single and multiple ascending dose study is PL-8177's first-ever human clinical trial.
During the preliminary, PL-8177 will be managed through subcutaneous infusion.

Up to 52 healthy volunteers are expected to participate in the study, and final results are anticipated by the third quarter of this year.

Stephen Wills, chief financial officer and chief operating officer of Palatin Technologies, stated: Since this is our second melanocortin peptide to enter clinical development, this is a significant milestone for Palatin.

“We continue to expand our pipeline of novel peptide therapeutics targeting the melanocortin system beyond bremelanotide, for which we expect to file an NDA with the FDA for Female Sexual Dysfunction Drugs Development Market later this quarter,” the company states.

“Our melanocortin receptor 1 (MC1r) peptides have the potential to treat a wide range of inflammatory diseases, and we are excited about this. This year, we anticipate the clinical development of additional compounds.

The synthetic cyclic heptapeptide PL-8177 from Palatin has been shown to be effective in animal models of inflammatory bowel disease.

Additionally, the formulation is a potent agonist with sub-nanomolar affinity binding and EC50 functional values at human MC1r.