Palisade Bio (NASDAQ:PALI) has announced that it has received a No Objection Letter from Health Canada for its Phase 1 clinical trial of PALI-2108 for the treatment of ulcerative colitis (UC).
The orally-administered PDE4 inhibitor prodrug, PALI-2108, is locally bioactivated in the colon and is in development for patients with UC. The primary objective of the single-center, double-blind, placebo-controlled study is focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, in conjunction with an open-label study involving a patient cohort with UC.
“Patients are actively seeking new and more effective treatment options for their ulcerative colitis. Currently, existing therapies achieve complete remission in fewer than a quarter of patients, and many of the most effective treatments involve injections or carry black box warnings due to serious side effects. A safe and effective oral medication for UC would be highly desirable for the majority of patients,” said Florian Rieder, MD, a member of the Palisade Bio Clinical Advisory Board, Associate Staff in the Department of Gastroenterology, Hepatology, and Nutrition, and an Investigator in the Department of Pathobiology at the Cleveland Clinic.
