Cure8 news brief
Early human data suggest PALI-2108 reaches intestinal tissue and produced short-term clinical, endoscopic, and biomarker changes in very small Phase 1 cohorts, supporting larger Phase 2 trials that could determine if this oral PDE4-targeting drug helps people with UC or Crohn’s disease.
Adult patients with ulcerative colitis or Crohn’s disease, clinicians treating IBD, IBD researchers, and people interested in emerging oral therapies.
PALI-2108 is an investigational, once-daily oral prodrug meant to activate in the terminal ileum and colon; its active metabolite (PALI-0008) inhibits PDE4 to reduce inflammatory signaling.
The presented Phase 1 data come from very small, open-label cohorts (five UC patients treated 7 days; five Crohn’s patients treated 14 days), so results are preliminary and not controlled.
The company reports clinical, endoscopic, histologic, biomarker, pharmacokinetic, and exploratory transcriptomic signals that the drug reaches intestinal tissue at higher concentrations than plasma and that short-term biological effects were seen. Safety signals in these cohorts were limited to mild adverse events with no discontinuations.
Palisade is moving into randomized Phase 2 trials (larger placebo-controlled studies) to test efficacy and safety; those trials will be needed to confirm whether the early signals translate into meaningful benefit.
These Phase 1 results are from tiny, open-label cohorts without placebo controls and short treatment duration; findings are preliminary and require confirmation in larger, randomized Phase 2 studies. The article is a company-reporting business news item summarizing conference presentations rather than a peer-reviewed paper.
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.
Early clinical data suggest PALI-2108 may affect both inflammation and fibrosis in Crohn’s disease and shows biomarker changes (like fecal calprotectin) that could matter to people monitoring disease activity.
People with IBD and their clinicians want ways to predict which advanced therapy will work best. This review summarizes current evidence and shows that, despite many studies, no biomarker is reliably ready for routine...
Early-phase trials test whether new treatments are safe and show biological activity. This study measures fecal calprotectin, a biomarker of intestinal inflammation, so it could provide early signals about whether ND-12...
