Palisade Bio Advances Crohn’s Disease Trial with FDA IND Clearance…

Event summary

FDA cleared Palisade Bio’s IND application for PALI-2108, enabling a Phase 2 trial in moderate to severe Crohn’s disease.
The ASCENTRA-CD trial will enroll approximately 60 patients, with first dosing targeted for Q1 2027 and primary efficacy readout in Q1 2028.
PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon.
The trial builds on prior clinical experience showing favorable tolerability, targeted tissue exposure, and encouraging endoscopic activity.

The big picture

Palisade Bio’s FDA clearance for PALI-2108 marks a strategic expansion into Crohn’s disease, complementing its ongoing ulcerative colitis trial. The move underscores the company’s focus on addressing unmet needs in inflammatory bowel disease (IBD) with a differentiated prodrug approach. The broader Phase 2 program aims to generate comprehensive clinical data, potentially positioning PALI-2108 as a competitive option in the crowded IBD therapy landscape.

What we're watching

Clinical Efficacy: Whether PALI-2108 can demonstrate significant endoscopic response in moderate to severe Crohn’s disease patients by Q1 2028.
Development Pace: The speed at which Palisade Bio can advance its Phase 2 program across both ulcerative colitis and Crohn’s disease.
Market Differentiation: How PALI-2108’s targeted activation and once-daily dosing will position it against existing therapies in the IBD market.