Palisade Bio (PALI) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PALI-2108, allowing the company to move forward with its global Phase 2 ASCENTRA-UC clinical trial in patients with Ulcerative Colitis (UC). The ASCENTRA-UC study is designed to evaluate the safety, tolerability, and efficacy of PALI-2108, a novel orally administered, locally activated phosphodiesterase-4 (PDE4) inhibitor developed to target inflammation directly in the colon while minimizing systemic exposure. Following the FDA's IND clearance, Palisade Bio plans to begin patient enrollment in the global Phase 2 trial, marking an important clinical milestone for the company's lead drug candidate. Key Highlights ✅ FDA clears IND application for PALI-2108 🌍 Company plans to initiate the global Phase 2 ASCENTRA-UC trial 🩺 Target indication: Ulcerative Colitis (UC) 💊 PALI-2108 is designed as a locally activated oral PDE4 inhibitor to reduce intestinal inflammation while limiting systemic side effects. 📈 IND clearance enables the company to advance clinical development and evaluate the therapy's potential efficacy and safety in UC patients. Why It Matters FDA IND clearance is a critical regulatory milestone that allows Palisade Bio to begin Phase 2 clinical testing. Positive results from the ASCENTRA-UC trial could support further development of PALI-2108 as a potential new treatment option for patients with Ulcerative Colitis, a chronic inflammatory bowel disease with significant unmet medical need.