Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108

Core Insights - PALI-2108 has shown safety and tolerability with no serious adverse events, supporting its potential as a once-daily oral therapy for ulcerative colitis and fibrostenotic Crohn's disease [1][2][3] Clinical Data Summary - Phase 1b study demonstrated a 100% clinical response rate in patients with moderate-to-severe ulcerative colitis, with significant histological and biomarker improvements [2][4] - Key findings from the Phase 1b study include a mean reduction of 62.8% in the modified Mayo score and a decrease in fecal calprotectin in 4 out of 5 patients [4] - Phase 1a study confirmed extended drug exposure with colon tissue drug concentrations remaining above target levels for over 36 hours post-dose, supporting a once-daily dosing regimen [5][10] Mechanism of Action - PALI-2108 is designed to selectively inhibit PDE4 in the distal ileum and colon, utilizing a microbiome-activated mechanism to enhance local bioactivation and minimize systemic exposure [7] - The drug demonstrated significant immunomodulatory effects, including a 40% average reduction in tissue lymphocytes and a 51% decrease in PDE4B expression [4][10] Future Development Plans - The company plans to submit an Investigational New Drug (IND) application for a Phase 2 study in the first half of 2026, following the completion of ongoing studies [1][5]