Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)

Core Viewpoint - Palisade Bio has received a No Objection Letter from Health Canada for its Phase 1 Clinical Trial Application for PALI-2108, a potential treatment for ulcerative colitis (UC), which is expected to grow to nearly $10 billion by 2028 [1][2]. Company Summary - Palisade Bio is a biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [7]. - The company aims to transform the treatment landscape with its targeted approach [7]. Clinical Trial Details - The Phase 1 study for PALI-2108 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients, with approximately 90 patients to be enrolled [3][5]. - The study design includes a single-center, double-blind, placebo-controlled format for healthy subjects and an open-label study for UC patients [3]. - The primary objective is to assess the safety and tolerability of single and repeated oral doses of PALI-2108, while secondary objectives will focus on pharmacokinetics and the effect of food on drug absorption [5]. Market Need - There is a significant medical need for effective treatments for UC, as current therapies achieve complete remission in fewer than 25% of patients, and many effective treatments involve injections or have serious side effects [4]. - A safe and effective oral medication for UC would be highly desirable for the majority of patients [4]. Future Plans - The company is on track to commence site initiation and enrollment for the clinical study before the end of the year [6].