Clinical Read2026-10-12

PALI-2108 - (ASCENTRA-CD)

Palisade Bio Inc.PALI
Indication
Fibrostenotic Crohn's Disease (FSCD)
Stage
phase1
Event
Phase 1b
Details

October 12, 2026: Palisade Bio (NASDAQ: PALI) reported five ACG 2026 poster presentations supporting ongoing Phase 2 development of PALI-2108, an oral locally activated PDE4 inhibitor prodrug, in ulcerative colitis (UC) and Crohn’s disease.

In UC (Poster P3504), five moderate-to-severe patients treated open-label for 7 days all achieved clinical response and 2/5 achieved remission; modified Mayo score fell 62.8% on average, with improvements in Nancy, Robarts, and Geboes histology indices. Colonic cAMP increased in 4/5, PDE4B expression decreased in 5/5, and fecal calprotectin fell in 4/5. ASCENTRA-UC is ongoing, testing once-daily 15 mg and 30 mg versus placebo in about 204 patients.

In fibrostenotic Crohn’s disease (Poster P3611), five adults treated for 14 days had all-mild adverse events, no serious adverse events, and no discontinuations. Mean SES-CD improved 47.5%; 2/5 achieved endoscopic response and 2/5 remission. Ileal tissue cAMP increased, fecal calprotectin fell, and exploratory plasma biomarkers suggested collagen-degradation/remodeling effects.

Poster P3413 showed ileal/colonic active-metabolite levels about sevenfold above peak plasma in the evaluated cohort and 30 mg once-daily exposure above estimated PDE4 IC90 over 24 hours, supporting once-daily dosing. Poster P3412 supported microbiome-mediated prodrug activation without significant short-term microbiome diversity changes. Poster P3505 described exploratory transcriptomic response signatures for potential patient stratification. Two posters (P3413, P3504) received ACG Presidential Poster Awards.