Canadian clearance supports site activation and enrollment in the global study of once-daily oral PALI-2108
Primary efficacy results from approximately 204 patients with moderately to severely active ulcerative colitis expected in the second half of 2027
Denver, CO, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation prodrugs for patients living with inflammatory and fibrotic diseases, today 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 (UC).
The clearance enables Palisade to advance clinical trial activities in Canada, expanding the study’s geographic reach and supporting planned enrollment. Together with prior regulatory clearance in the United States, this milestone advances the Company’s global site activation and enrollment strategy. 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.”
ASCENTRA-UC is a global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in patients with moderately to severely active UC. The study is expected to enroll approximately 204 patients and will evaluate once-daily 15 mg and 30 mg doses of PALI-2108 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. The study also includes a 36-week maintenance phase extension designed to evaluate durability of response and longer-term safety through Week 48.
“PALI-2108 is designed to combine the convenience of once-daily oral dosing with targeted activation in the terminal ileum and colon,” said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. “ASCENTRA-UC builds on the clinical and pharmacologic findings observed to date and will rigorously evaluate whether this approach can translate into clinical remission and mucosal improvement. Expanding the study into Canada supports enrollment and brings us closer to answering these important clinical questions.”
About PALI-2108
PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon. Across Phase 1 studies in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease, PALI-2108 demonstrated favorable safety and tolerability, differentiated pharmacokinetics and sustained PDE4 inhibition above IC90, supporting advancement into Phase 2 development.
About Palisade Bio
Palisade Bio, Inc. (Nasdaq: PALI) is a clinical-stage biopharmaceutical company developing prodrugs for patients living with inflammatory and fibrotic diseases.
The Company’s lead clinical product candidate, PALI-2108, is being advanced into Phase 2 clinical trials as a treatment for patients living with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). Despite the availability of multiple biologic and small-molecule therapies, many patients with UC and CD do not achieve durable remission, lose response over time, or discontinue treatment because of safety or tolerability limitations. The Company believes PALI-2108 has the potential to address these limitations through once-daily oral dosing, targeted lower-intestinal bioactivation and broad PDE4-mediated anti-inflammatory activity.
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. 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, 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 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; 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
[email protected]