Palisade Bio to Present Preclinical Results for PALI-2108 Demonstrating Engagement of Key Fibrotic Pathways of Crohn's Disease and Ulcerative Colitis (UC)

Core Insights - Palisade Bio announced promising preclinical results for PALI-2108, a local PDE4 inhibitor prodrug, which may enhance efficacy and safety for treating fibrostenotic Crohn's disease compared to traditional therapies [1][3][4] - The data will be presented at the 8th Annual Antifibrotic Drug Development Summit, highlighting the potential of PALI-2108 to minimize off-target effects while maximizing therapeutic efficacy [2] Group 1: PALI-2108 Development - PALI-2108 demonstrated a dose-dependent effect on key fibrotic pathways in a DSS colitis mouse model, indicating its potential as an effective treatment for fibrostenotic Crohn's disease [1][3] - The study revealed that PALI-2108 modulates 187 genes involved in the main fibrotic pathways of inflammatory bowel disease (IBD), suggesting its ability to reverse or prevent fibrotic progression [3][4] Group 2: Mechanism and Safety Profile - PALI-2108 was found to reduce key intracellular markers of inflammation and fibrosis in the colon while increasing cAMP levels, which is crucial for tissue homeostasis [4] - The localized activation of PALI-2108 aims to reduce systemic side effects commonly associated with traditional systemic PDE4 inhibitors, such as nausea [4] Group 3: Clinical Trials and Future Outlook - The company is currently conducting a Phase 1 single-center, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in healthy volunteers, with topline data expected in the first half of 2025 [5][6] - PALI-2108 is part of the company's precision medicine strategy, aimed at identifying patient responders for future clinical studies [6]