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
The completed Phase 1 program found PALI-2108 generally well tolerated, while earlier ulcerative colitis findings remain preliminary and uncontrolled.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Palisade Bio (Nasdaq: PALI) dosed the first patient in ASCENTRA-UC, its global Phase 2b ulcerative colitis trial of PALI-2108. The randomized, placebo-controlled study will evaluate two once-daily oral doses in approximately 204 patients with moderately to severely active disease. Its primary endpoint is clinical remission at Week 12; the company expects 12-week induction topline results in Q4 2027.
Palisade has activated 29 of 30 planned U.S. sites and is progressing toward approximately 115 sites globally. Canada has cleared the clinical trial application; submissions remain under review in Europe and other international countries. The completed Phase 1 program reported no serious adverse events. In a preliminary, uncontrolled Phase 1b cohort treated for seven days, all five evaluable patients achieved clinical response and two achieved remission based on the modified Mayo Score, a disease activity measure.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst patient dosed advances PALI-2108 into the randomized, placebo-controlled Phase 2b ASCENTRA-UC study.
- Minor point29 of 30 planned U.S. sites activated; the company reports site activation ahead of schedule.
- Minor pointCanadian clinical trial application clearance supports international study expansion.
- Minor point. Forward-looking: it has not happened yet and may not happen.Approximately 115 total sites targeted as global expansion progresses.
- Minor point. Forward-looking: it has not happened yet and may not happen.Q4 2027 is the company's expected timing for 12-week induction topline results.
3 minor points
- Minor pointCompleted Phase 1 program found PALI-2108 generally well tolerated, with no serious adverse events reported.
- Minor pointAll five evaluable Phase 1b patients achieved clinical response; two achieved remission after seven days.
- Minor pointPhase 1 findings showed sustained active-metabolite exposure and evidence of activity on the targeted PDE4 pathway.
Negative
- Minor pointEuropean and other international submissions remain under review.
- Minor pointPhase 1b efficacy findings were preliminary, open-label and uncontrolled, with only five enrolled patients treated for seven days.
Key Figures
- ASCENTRA-UC planned enrollment
- Approximately 204 patients
- Global Phase 2b study
- U.S. sites activated
- 29 of 30 planned sites
- ASCENTRA-UC
- Global site plan
- ~115 total sites
- Global expansion
- Induction period
- 12 weeks
- ASCENTRA-UC
- Topline results timing
- Q4 2027
- Induction results
- Exploratory UC cohort
- Five enrolled patients
- Phase 1b; treated for seven days
- Clinical response
- All five evaluable patients
- Exploratory Phase 1b UC cohort
- Clinical remission
- Two patients
- Exploratory Phase 1b UC cohort
Previous Clinical trial Reports
-
Five UC patients responded and two remitted in uncontrolled Phase 1b findings preceding this controlled study.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pde4 inhibitor medical
pharmacokinetic medical
pharmacodynamic medical
modified mayo score medical
placebo-controlled medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
PALI-2108 is an investigational, gut-activated, once-daily oral PDE4 inhibitor prodrug designed for sustained exposure and anti-inflammatory activity with the potential to improve tolerability
29 of 30 planned U.S. sites already activated
Global expansion progressing toward ~115 total sites, with CTA clearance in Canada and submissions under review in Europe and other international countries
12-week induction topline results expected Q4 2027
Denver, CO, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases, today 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 (UC).
“Dosing the first patient in ASCENTRA-UC represents an important milestone for Palisade and for people living with ulcerative colitis, many of whom still lack durable, well-tolerated oral treatment options,” said JD Finley, Chief Executive Officer of Palisade Bio. “We believe PDE4 inhibition remains a compelling anti-inflammatory and anti-fibrotic mechanism. PALI-2108’s prodrug design is intended to address historical tolerability limitations associated with this class. Our goal is to develop a once-daily oral therapy that can deliver meaningful disease control on its own, with longer-term potential in combination with therapies targeting complementary pathways. With U.S. enrollment underway and global expansion progressing, we look forward to reporting topline induction results in the fourth quarter of 2027.”
PALI-2108 is an investigational, once-daily oral PDE4 inhibitor prodrug designed for targeted bioactivation in the terminal ileum and colon. Its pharmacologic profile is intended to provide high intestinal tissue exposure and sustained systemic exposure while potentially mitigating tolerability limitations historically associated with systemic PDE4 inhibition. In the completed Phase 1 program, PALI-2108 was generally well tolerated with no serious adverse events reported and showed pharmacokinetic and pharmacodynamic findings supportive of further development. In a small, open-label, exploratory Phase 1b UC cohort of five enrolled patients treated for seven days, all five evaluable patients achieved clinical response and two achieved clinical remission based on the modified Mayo Score. These preliminary, uncontrolled findings support further evaluation in the randomized, placebo-controlled ASCENTRA-UC study. The Company has activated 29 of 30 planned U.S. sites and is advancing site start-up in Canada and other international countries.
“ASCENTRA-UC is designed to rigorously evaluate the efficacy and safety of PALI-2108 across two once-daily oral dose levels, with clinical remission at Week 12 as the primary endpoint,” said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. “The study will also assess clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement, along with the durability of treatment response. Our Phase 1 findings showed early signals of clinical activity, sustained exposure of the active metabolite, and pharmacodynamic evidence of PDE4 pathway modulation. Clinical site activation is, as of now, ahead of schedule, with substantially all U.S. sites now activated. We look forward to determining whether these findings translate into meaningful clinical benefit in a larger, controlled patient population.”
About the ASCENTRA-UC Phase 2b Clinical Trial
ASCENTRA-UC is a global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b clinical trial designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in patients with moderately to severely active ulcerative colitis. The study is expected to enroll approximately 204 patients and evaluate two once-daily dose levels of PALI-2108, 15 mg and 30 mg, compared with placebo. The primary endpoint is clinical remission at Week 12, as measured by the Modified Mayo Score. Key secondary endpoints include clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI). Following the 12-week induction period, eligible patients will continue into a 36-week maintenance phase designed to evaluate the durability of response through Week 48.
Primary efficacy results from the 12-week induction period are expected in the fourth quarter of 2027.
About PALI-2108
PALI-2108 is an investigational oral PDE4 inhibitor prodrug designed for localized bioactivation in the terminal ileum and colon and being developed for once-daily dosing. Its active metabolite, PALI-0008, potently inhibits PDE4 isoforms A, B and D, increasing intracellular cAMP to modulate inflammatory signaling. Phase 1 studies have provided evidence of high intestinal exposure, sustained systemic exposure, favorable short-term tolerability and early clinical activity, supporting Phase 2 development in UC and Crohn’s disease. PALI-2108 has not been approved for any indication.
About Palisade Bio
Palisade Bio is a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases. Its lead program, PALI-2108, is in Phase 2 development in ulcerative colitis, with a Phase 2 study in Crohn’s disease underway.
For more information, please go to www.palisadebio.com.
Forward Looking Statements
Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “designed to,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include but are not limited to: implied or express statements regarding the pharmacological properties, safety, tolerability, clinical response and efficacy, and therapeutic potential of PALI-2108, dosing levels and timing of key PALI-2108 development milestones such as regulatory submissions and approvals, trial enrollments and commencements and efficacy readouts; the design, conduct, enrollment and expected timing of results of the ASCENTRA-UC trial, including site activation and the expansion of the trial outside the United States; the potential of PALI-2108 to improve tolerability relative to other PDE4 inhibitors; plans to develop PALI-2108 in Crohn’s disease; and the Company’s expected cash runway. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the Company’s ability to activate clinical sites on the anticipated timeline; the timing and outcome of regulatory reviews of clinical trial applications outside the United States; the Company’s reliance on third parties, including contract research organizations and clinical sites; the risk that prior results, such as signals of safety, clinical response and efficacy, dosing or durability of effect, observed from preclinical or clinical trials with a limited number of patients, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; the risk that safety or tolerability findings emerge in larger, controlled studies; the Company’s need for additional capital to complete its clinical development programs; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2026, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Palisade Bio testing in the ASCENTRA-UC trial?
ASCENTRA-UC is a randomized, placebo-controlled Phase 2b trial evaluating two once-daily oral dose levels of PALI-2108 in approximately 204 patients with moderately to severely active ulcerative colitis. The primary endpoint is clinical remission at Week 12.
When does Palisade Bio expect ASCENTRA-UC results?
Palisade Bio expects 12-week induction topline results in Q4 2027. The first patient has been dosed, and 29 of 30 planned U.S. sites have been activated.
What else will Palisade Bio's ASCENTRA-UC study measure besides remission?
ASCENTRA-UC will also assess clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement, along with durability of treatment response. These measures examine symptom response and improvement in the intestinal lining through visual examination and tissue assessment.