Palisade Bio, Inc.

Palisade Bio Announces First Patient Dosed in Global Phase 2b ASCENTRA-UC Study Evaluating Once-Daily Oral PALI-2108 for the Treatment of Ulcerative Colitis

Palisade Bio dosed the first patient in its global Phase 2b ASCENTRA-UC trial of once-daily oral PALI-2108 in roughly 204 patients with moderately to severely active ulcerative colitis. Site activation is ahead of schedule with 29 of 30 planned U.S. sites live; the company targets ~115 total sites globally, with Canada CTA clearance and European submissions under review. The primary endpoint is clinical remission at Week 12, with a 36-week maintenance phase through Week 48. Topline 12-week induction results are expected in Q4 2027 — a long catalyst gap. Phase 1b signals (all 5 patients responding in a small open-label cohort) are preliminary and uncontrolled.

•4d ago

Palisade Bio Presents Rapid Endoscopic Improvement and New Translational Evidence for PALI-2108 in Inflammatory Bowel Disease at UEG Week 2026

Palisade Bio presented clinical and translational data for PALI-2108 at UEG Week 2026, highlighting a 47.5% reduction in mean endoscopic disease activity and a 58.8% reduction in fecal calprotectin after 14 days in a five-patient fibrostenotic Crohn's disease cohort. A separate five-patient ulcerative colitis cohort showed clinical response in all five patients at Day 7, and tissue analyses demonstrated intestinal exposure of the active metabolite roughly 7.3-fold above peak plasma levels, supporting once-daily oral dosing. The company is enrolling the Phase 2b ASCENTRA-UC study in approximately 204 patients and initiating a Phase 2a Crohn's disease study. Management cautions the findings are exploratory, from small open-label cohorts without placebo controls, and require confirmation in larger controlled trials.

•12d ago

Palisade Bio Presents New Clinical, Pharmacokinetic, Pharmacodynamic and Mechanistic Data Strengthening the Phase 2 Rationale for PALI-2108 in Ulcerative Colitis and Crohn’s Disease at ACG 2026

Palisade Bio presented five posters at ACG 2026 supporting the Phase 2 rationale for PALI-2108, its gut-activated PDE4 inhibitor prodrug, in ulcerative colitis and Crohn's disease. Phase 1a/1b data showed early activity — all five UC patients achieved clinical response with a 62.8% mean reduction in modified Mayo score, and fibrostenotic Crohn's patients showed a 47.5% mean SES-CD reduction after 14 days — with no serious adverse events. Two posters received ACG Presidential Poster Awards, a distinction given to roughly 5% of accepted abstracts. The Phase 2 ASCENTRA-UC study will test 15 mg and 30 mg once-daily doses versus placebo in approximately 204 patients. The company cautions these were small, short-duration, open-label studies without placebo control; results require confirmation in larger trials.

•20d ago

Palisade Bio to Present Clinical and Translational Data for PALI-2108 in Ulcerative Colitis and Crohn’s Disease at UEG Week 2026

Palisade Bio's lead program PALI-2108 will be featured in four presentations at United European Gastroenterology (UEG) Week 2026, taking place October 17-20 in Barcelona. The lineup includes an oral presentation of Phase 1b findings in fibrostenotic Crohn's disease showing early endoscopic improvement and PDE4 target engagement, plus three moderated posters covering gut-targeted exposure, rapid clinical response in ulcerative colitis, and a response-predicting biomarker. PALI-2108 is being advanced into Phase 2 trials in both ulcerative colitis and Crohn's disease as a once-daily oral PDE4 inhibitor prodrug.

•1mo ago

Palisade Bio Expands Global Phase 2b ASCENTRA-UC Program with Health Canada CTA Clearance

Health Canada cleared Palisade Bio's Clinical Trial Application for ASCENTRA-UC, its global Phase 2 study of once-daily oral PALI-2108 in moderately to severely active ulcerative colitis. The clearance, following prior U.S. regulatory clearance, enables Canadian site activation and supports planned enrollment of approximately 204 patients in the randomized, placebo-controlled, dose-ranging trial testing 15 mg and 30 mg doses. The company remains on track to begin patient dosing in H2 2026, with primary efficacy results from the 12-week induction period expected in H2 2027; the trial also includes a 36-week maintenance extension through Week 48.

•1mo ago

Palisade Bio Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of PALI-2108 Into Phase 2 Development

Palisade Bio reported a Q2 net loss of $10.6 million, or $0.05 per share, driven by increased R&D and G&A expenses as the company prepares for Phase 2 trials. The company ended the quarter with $125.2 million in cash, which management believes is sufficient to fund operations through key clinical readouts expected in 2027 and 2028. The company is advancing PALI-2108 into Phase 2 development for ulcerative colitis and Crohn's disease, with the ASCENTRA-UC trial expected to commence in the second half of 2026. Phase 1 data demonstrated favorable safety and tolerability, with 5 out of 5 UC patients achieving clinical response. Palisade strengthened its board with the appointment of biopharmaceutical veterans Robert Baltera and Jordan Zwick to support the clinical advancement of PALI-2108.

•2mo ago

Palisade Bio Receives FDA Clearance of IND for PALI-2108 and Plans to Initiate Global Phase 2 ASCENTRA-UC Study in Ulcerative Colitis

Palisade Bio received FDA clearance of its IND application for PALI-2108, enabling the initiation of the global Phase 2 ASCENTRA-UC study in patients with moderately to severely active ulcerative colitis. The multicenter, double-blind trial expects to enroll approximately 204 patients across North America and Europe to evaluate two once-daily dose levels versus placebo. Primary efficacy results are anticipated in the second half of 2027, and the company plans to submit an IND for a Crohn's disease study in the second half of 2026.

•4mo ago

Palisade Bio Reports First Quarter 2026 Financial Results and Highlights Continued Clinical Progress of PALI-2108

Palisade Bio reported Q1 financial results with a net loss of $0.05 per share, driven by a significant ramp in R&D spending to $6.4 million as PALI-2108 advances toward Phase 2 trials. The company ended the quarter with $132.6 million in cash, providing a runway that management expects to fund operations through key efficacy readouts in 2028. Clinical development remains on track, with a Phase 2 ulcerative colitis trial targeted for initiation in Q3 2026 following positive Phase 1b data.

•5mo ago

Palisade Bio Reports Additional Phase 1a/b Data Demonstrating Colon-Targeted Exposure and Sustained IC90 Coverage Supporting Once-Daily Dosing in Ulcerative Colitis

Palisade Bio reported additional Phase 1a/b data for PALI-2108 showing colon-targeted exposure and sustained IC90 coverage supporting once-daily dosing in ulcerative colitis. The analysis demonstrated significant biomarker improvements including approximately 70% reduction in fecal calprotectin and 58% reduction in Nancy score, with pre-dose trough concentrations exceeding the IC90 threshold. Management noted the favorable pharmacokinetic profile strengthens the case for the therapy as the company advances towards two Phase 2 clinical studies.

•5mo ago