FDA Approves Phase 2 Trial for Palisade Bio's Crohn's Disease Drug

The U.S. Food and Drug Administration has approved the Phase 2 trial for Palisade Bio's PDE4 inhibitor prodrug, PALI-2108, for the treatment of moderate to severe Crohn's disease. The trial, named ASCENTRA-CD, is a multicenter, open-label, single-arm study featuring a 12-week induction phase followed by a 36-week maintenance phase. Approximately 60 patients will be enrolled in the trial, with first patient dosing targeted for the first quarter of 2027. The primary endpoint for the trial is an endoscopic response at Week 12, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease, based on blinded central endoscopic review. Key secondary endpoints at Week 12 include clinical remission, endoscopic remission, and patient-reported outcomes of abdominal pain and stool frequency, with additional assessments through Week 48. PALI-2108 has previously been evaluated in patients with fibrostenotic Crohn's disease in earlier studies. Palisade Bio is also advancing the Phase 2 development of PALI-2108 in ulcerative colitis via the ASCENTRA-UC trial. The primary efficacy readout for the ASCENTRA-CD trial is targeted for the first quarter of 2028.