Palisade Bio Receives FDA Clearance for Phase 2 Crohn’s Disease Trial
News related to:Palisade Bio · 1 min read
Denver, CO, Sept. 22, 2026 /CourierPR/ -- Palisade Bio, a clinical-stage biopharmaceutical company, has received FDA clearance for its Investigational New Drug (IND) application for PALI-2108, a prodrug designed to treat inflammatory and fibrotic diseases. This clearance paves the way for the company to initiate the Phase 2 ASCENTRA-CD clinical trial, which is expected to enroll approximately 60 patients with moderate to severe Crohn’s disease.
The ASCENTRA-CD trial is set to begin in the first quarter of 2027, with the primary efficacy readout targeted for the first quarter of 2028. The trial will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of PALI-2108. Patients will undergo a 14-day dose titration to the target dose of 30 mg of PALI-2108, administered orally once daily. The study will consist of a 12-week induction phase followed by a 36-week maintenance phase.
The primary endpoint of the trial is endoscopic response at Week 12, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD), based on blinded central endoscopic review. Key secondary endpoints include clinical remission, endoscopic remission, PRO-2 remission (a patient-reported outcome of abdominal pain and stool frequency), clinical response, and combined clinical remission and endoscopic response, with additional maintenance assessments through Week 48.
Palisade Bio’s lead clinical product candidate, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon. Across Phase 1 studies in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease, PALI-2108 demonstrated favorable safety and tolerability, differentiated pharmacokinetics, and sustained PDE4 inhibition above IC90, supporting advancement into Phase 2 development.
The company’s Phase 2 development program now advances in both ulcerative colitis and Crohn’s disease, with the ASCENTRA-UC in ulcerative colitis and ASCENTRA-CD in Crohn’s disease designed to generate a broader clinical dataset around the efficacy, safety, and pharmacology of PALI-2108. Together, these trials aim to provide a comprehensive understanding of the drug’s potential in treating inflammatory bowel disease.