Cure8 news brief
FDA clearance lets Palisade start a Phase 2 trial of PALI-2108 in moderate-to-severe Crohn’s disease, which could matter to patients and clinicians watching new oral treatments targeted to the lower intestine.
Adults with Crohn’s disease (moderate-to-severe), clinicians treating IBD, IBD researchers, and patients interested in emerging oral therapies for IBD.
This is an industry press release reporting that the FDA cleared an Investigational New Drug application for PALI-2108 and that Palisade will start a multicenter, open-label, single-arm Phase 2 study (ASCENTRA-CD) with a 12-week induction and 36-week maintenance phase.
The primary endpoint is endoscopic response (≥50% SES-CD reduction) at Week 12 by blinded central read. The program builds on prior Phase 1/early clinical experience in fibrostenotic Crohn’s disease showing ileal/colonic exposure and PDE4 engagement.
The drug is described as a once-daily oral PDE4 inhibitor prodrug designed for local activation in the terminal ileum and colon to increase intestinal exposure while maintaining systemic pharmacology. The release frames the IND clearance as a regulatory milestone that expands PALI-2108 into Crohn’s disease alongside ongoing ulcerative colitis development.
This is a company press release summarizing an IND clearance and planned Phase 2 study; it contains trial design and timelines but no clinical outcomes. The prior clinical experience referenced is early-phase and not detailed in this release.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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