Palisade Bio Inc（PALI）资讯与事件PALIPalisade Bio Inc

Palisade Bio Doses First Patient in ASCENTRA-UC Trial

Palisade Bio announced that the first patient has been dosed in ASCENTRA-UC, its global Phase 2b clinical trial evaluating PALI-2108 in approximately 204 patients with moderately to severely active ulcerative colitis.

Palisade Bio Presents PALI-2108 Clinical Findings at UEG Week

Palisade Bio announced clinical and translational findings presented in one oral presentation and three moderated posters at United European Gastroenterology, or UEG, Week 2026, held October 17-20 in Barcelona, Spain. The findings connect targeted intestinal exposure to PALI-0008, the active metabolite of PALI-2108, with PDE4 target engagement, reduced intestinal inflammation and early clinical activity in ulcerative colitis, or UC, and fibrostenotic Crohn's disease, or FSCD. The new analyses build on previously reported Phase 1b results: a 47.5% reduction in mean endoscopic disease activity after 14 days in five patients with FSCD, and clinical response in all five patients in a separate UC cohort assessed after seven days. Palisade is enrolling the Phase 2b ASCENTRA-UC study and initiating a Phase 2a open-label study in Crohn's disease. Mean Simple Endoscopic Score for Crohn's Disease, or SES-CD, decreased by 47.5%. Two of five patients achieved endoscopic response, and two of five achieved endoscopic remission, defined as an SES-CD of 0-2. Reduced intestinal inflammation: Mean fecal calprotectin decreased by 58.8% from baseline. Ileal tissue cAMP increased, consistent with PDE4 target engagement; exploratory analyses identified an inverse association between changes in tissue cAMP and fecal calprotectin. Evidence of tissue-level activity: Paired biopsy analyses showed reductions in inflammatory-cell populations. Exploratory single-nucleus RNA analyses identified reduced PDE4D expression in ileal enterocytes in three of four patients with paired sprovamples. Exploratory stricture observation: One stricture that could not be traversed by the endoscope at baseline was traversable at Day 14. This single-patient observation does not establish reversal of fibrosis. Favorable short-term tolerability: All reported adverse events were mild. No serious adverse events, treatment discontinuations, nausea, vomiting, diarrhea or headache were reported in this five-patient cohort. Exploratory changes in collagen-degradation and macrophage-associated biomarkers were consistent with potential extracellular matrix remodeling and support further investigation of PALI-2108's effects on fibrotic disease. These analyses do not establish an antifibrotic clinical benefit.

Palisade Bio Receives Health Canada Approval for Ascentra-UC Clinical Trial

Palisade Bio announced that Health Canada has cleared the Company's Clinical Trial Application, CTA, for Ascentra-UC, its global Phase 2 study evaluating PALI-2108 in patients with moderately to severely active ulcerative colitis. The clearance enables Palisade to advance clinical trial activities in Canada, expanding the study's geographic reach and supporting planned enrollment. Primary efficacy results from the study's 12-week induction period are expected in the second half of 2027. "Health Canada clearance represents another important execution milestone as we advance Ascentra-UC globally," said JD Finley, Chief Executive Officer of Palisade Bio. "Our focus is on efficiently activating sites, expanding patient access to the study and delivering the clinical data needed to define PALI-2108's potential in ulcerative colitis. We remain on track to begin patient dosing in the second half of 2026, with primary efficacy results expected in the second half of 2027."