Core Insights - Palisade Bio has initiated a Phase 1b clinical study for PALI-2108, a first-in-class PDE4 inhibitor prodrug targeting fibrostenotic Crohn's disease (FSCD), with topline data expected in Q1 2026 [2][3][5] Group 1: Clinical Development - The Phase 1b study will enroll approximately 6 to 12 patients and aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 over a 14-day treatment period [3][4] - PALI-2108 is designed for targeted activation in the terminal ileum and colon, providing high local tissue exposure with minimal systemic absorption [3][6] - The study will also assess tissue-level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs) [4] Group 2: Future Plans - Data from the Phase 1b study, along with results from the Phase 1a/1b ulcerative colitis program, are expected to support Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026 [5] - The company aims to transform the treatment landscape for autoimmune, inflammatory, and fibrotic diseases through its targeted therapeutic approach [7]

Core Insights - PALI-2108 shows favorable safety profile with no serious adverse events and promising efficacy in ulcerative colitis [1][5] - The Phase 1b study demonstrated a 100% clinical response rate, with significant improvements in various clinical and biomarker measures [2][5] - The drug is positioned as a potential first-in-class therapy for both ulcerative colitis and fibrostenotic Crohn's disease [3][4] Clinical Findings - Phase 1b UC cohort had all patients responding to treatment, with 2 out of 5 achieving remission in just seven days [2][5] - Significant reductions in modified Mayo score (62.8% mean reduction) and histological improvements were observed [5] - Biomarker analyses indicated a reduction in inflammatory markers and normalization of 186 fibrotic gene markers [5] Development Timeline - Patient dosing for the Phase 1b FSCD study is expected to start in the second half of 2025, with Phase 2 IND submissions anticipated in the first half of 2026 [1][6] Mechanism and Design - PALI-2108 is designed for gut-restricted delivery, targeting the terminal ileum and colon, which minimizes systemic exposure and enhances local efficacy [7] - The drug's mechanism supports both anti-inflammatory and anti-fibrotic activities, making it a versatile therapeutic option [4][7] Company Overview - Palisade Bio is focused on developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, aiming to transform treatment landscapes with targeted approaches [8]