P0989Gut-Targeted PDE4 Inhibition with PALI-2108 Demonstrates Rapid Clinical, Histologic, and Biomarker Improvement in Ulcerative Colitis: Translational Findings from a Phase 1a Study

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Key Points

This trial aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical efficacy of PALI-2108 in patients with moderate-to-severe ulcerative colitis.
Adaptive Phase 1a/1b design
Single ascending dose in healthy volunteers
Multiple ascending dose trials
Titrated dosing in active ulcerative colitis patients
Assessment of clinical, histologic, and biomarker outcomes
Over 95% of adverse events were mild; no serious adverse events occurred.
Clinical improvement of 62.8% in the modified Mayo score after one week.
4 out of 5 patients showed elevated tissue cAMP levels and reduced lymphocytes.
Fecal calprotectin levels decreased by an average of 70.3%.
Histology indices showed significant reductions, validating the anti-inflammatory effect.

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Phase 1a trial demonstrates PALI-2108 improves biomarkers and clinical outcomes in ulcerative colitis, indicating its potential benefits.

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Heyer et al. (2026) studied this question.

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