Palatin Technologies has announced the enrolment of the first patient in the Phase II PL8177-205 clinical trial of PL8177 for ulcerative colitis (UC), a chronic large intestine disease.
PL8177-205 is a randomised, double-blind, multi-centre, placebo-controlled, adaptive design, and parallel group of the oral formulation of the melanocortin-1 receptor agonist (MC1r), PL8177, with once-a-day (QD) dosing in adult subjects with UC.
It will enrol up to 28 adults with active UC from nearly 22 sites.
Those who meet the eligibility criteria will be randomised and given either oral PL8177 or a placebo.
Palatin Technologies president and CEO Carl Spana said: “The relative speed, efficiency, and agility in which we designed, selected, completed pre-clinical activities, and commenced this study demonstrates our core capabilities and the robustness of our MC1r agonist platform.
“Initiating enrolment in this trial places Palatin one step closer to obtaining the relevant data demonstrating oral PL8177 is a potential treatment option for ulcerative colitis patients as an alternative therapy to immunosuppressive treatments, which have significant safety and tolerability concerns.”
Interim assessment of the PL8177-205 study is currently expected to take place in the first quarter of calendar year 2023. Final topline results are anticipated during the third quarter.
The clinical trial will use an adaptive design, with assessment by an independent data monitoring committee following the eight-week visit completion of the first 16 participants.
The Mayo Endoscopic Subscore, which assesses the disease level in the colon mucosa, is the trial’s primary endpoint.
PL8177 is a synthetic cyclic heptapeptide and showed efficacy in multiple animal inflammatory bowel disease models.
Last month, Palatin started subject recruitment for the Phase II clinical trial of PL8177.