Palatin says results of PL-8177 study met all primary,secondary endpoints
Palatin Technologies announced positive results of a micro-dose study of radiolabeled PL-8177 using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL-8177 is a patented melanocortin receptor 1 agonist with potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The main objective of the study was to demonstrate release of polymer-bound PL-8177 in the lower gastrointestinal tract after oral administration. Top line data showed favorable pharmacokinetics, and demonstrated PL-8177 was released in the lower gastrointestinal tract, supporting oral administration of PL-8177 using the delayed release polymer formulation. A secondary objective of the study was also met, demonstrating that PL-8177 is not systemically absorbed after oral administration. There was no intact PL-8177 or its metabolite detected in plasma after oral administration. The oral formulation was well tolerated and there were no adverse events observed.