Palisade Bio Wins FDA IND Clearance for PALI-2108 in Crohn's Disease
核心洞察
Palisade Bio has received FDA clearance of its IND for PALI-2108, allowing initiation of the Phase 2 ASCENTRA-CD trial in moderate to severe Crohn's disease (搜索).
ASCENTRA-CD is an open-label, single-arm study of approximately 60 adults, with a 12-week induction phase followed by 36 weeks of maintenance.
The primary endpoint is Week 12 endoscopic response, defined as at least a 50% reduction in SES-CD, with first patient dosing targeted for Q1 2027.
Palisade Bio has received FDA clearance of its Investigational New Drug application for PALI-2108, enabling initiation of the Phase 2 ASCENTRA-CD trial in patients with moderate to severe Crohn's disease (搜索). The clearance expands the company's Phase 2 program for the candidate across the two major forms of inflammatory bowel disease, alongside the ongoing ASCENTRA-UC study in ulcerative colitis (搜索).
ASCENTRA-CD is a multicenter, open-label, single-arm Phase 2 study designed to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics in approximately 60 adults. Patients undergo a 14-day dose titration to PALI-2108 30 mg orally once daily, followed by a 12-week induction phase and a 36-week maintenance phase. The primary endpoint is endoscopic response at Week 12, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (搜索) based on blinded central endoscopic review. Key secondary endpoints at Week 12 include clinical remission, endoscopic remission, PRO-2 remission, clinical response and combined clinical remission and endoscopic response, with maintenance assessments through Week 48. Palisade anticipates first patient dosing in Q1 2027 and a primary efficacy readout in Q1 2028.
PALI-2108 is a once-daily oral PDE4 (搜索) inhibitor prodrug designed for targeted activation in the terminal ileum and colon, generating high local intestinal exposure while supporting sustained systemic exposure. The candidate has already been evaluated in patients with fibrostenotic Crohn's disease (搜索), providing clinical experience with ileal and colonic tissue exposure, PDE4 target engagement and endoscopic activity. Across Phase 1 studies in healthy volunteers and patients with ulcerative colitis (搜索) and fibrostenotic Crohn's disease, PALI-2108 showed favorable safety and tolerability, differentiated pharmacokinetics and sustained PDE4 inhibition above IC90.
Source: Palisade Bio Receives FDA Clearance of IND for PALI-2108 in Crohn's Disease