ASCENTRA-UC expected to enroll up to 204 patients with moderately to severely active ulcerative colitis across North America and Europe
First patient enrollment anticipated in the second half of 2026; primary efficacy results expected in the second half of 2027
IND clearance marks a major development milestone for PALI-2108 and supports continued advancement of the Company's inflammatory bowel disease portfolio
Denver, CO, June 29, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade" or the "Company"), a clinical-stage biopharmaceutical company developing next-generation oral PDE4 inhibitor prodrugs for inflammatory bowel disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for PALI-2108, enabling initiation of the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis (UC).
The Company anticipates initiating patient enrollment in the second half of 2026, with primary efficacy results expected in the second half of 2027.
"FDA clearance of our IND application is a significant milestone for Palisade Bio and an important validation of the extensive preclinical, manufacturing and clinical work completed to advance PALI-2108 into Phase 2 development," said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. "We believe PALI-2108's novel prodrug design and targeted local bioactivation profile may offer a differentiated oral approach for patients living with inflammatory bowel disease. Supported by encouraging Phase 1 data in both ulcerative colitis and fibrostenotic Crohn's disease, we look forward to entering what we believe will be a value-defining stage of development for the program."
ASCENTRA-UC Phase 2 Trial Design
ASCENTRA-UC is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 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 durability of response through Week 48.
Pipeline Expansion: ASCENTRA-CD
In parallel with ASCENTRA-UC, the Company continues to advance development plans for Crohn's disease and currently expects to submit an IND application for ASCENTRA-CD in the second half of 2026. The Company believes the broad applicability of PALI-2108 across inflammatory bowel disease indications may provide opportunities to expand the program beyond ulcerative colitis.
To support execution of ASCENTRA-UC, Palisade Bio has partnered with PSI, the leading global contract research organization (CRO) in IBD, to manage the execution of the program. PSI brings extensive experience delivering complex phase 2 and phase 3 international clinical trials in immunology and gastroenterology.
PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the terminal ileum and colon. The Company believes this differentiated approach may enable localized gastrointestinal activity while maintaining a pharmacokinetic profile supportive of chronic administration. Positive Phase 1 clinical data previously reported by the Company demonstrated encouraging safety, tolerability, pharmacokinetic and pharmacodynamic results supporting continued clinical development.
About Palisade Bio
Palisade Bio, Inc. (Nasdaq: PALI) is a clinical-stage biopharmaceutical company advancing a next-generation oral PDE4 inhibitor prodrug designed to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases. Through its prodrug platform and precision pharmacology strategy, Palisade Bio is committed to transforming proven PDE4 biology into better, safer oral therapies for patients living with chronic inflammatory and fibrotic diseases.
The Company's lead program, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the ileum and colon, initiating targeted PDE4 inhibition at sites of disease while enabling systemic distribution of the active drug. PALI-2108 has demonstrated positive results in a Phase 1a and two Phase 1b clinical trials, including studies in ulcerative colitis and fibrostenotic Crohn's disease.
Palisade Bio is now advancing Phase 2 clinical development in UC and Crohn's disease. 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: the potential mechanisms of action and therapeutic benefits of PALI-2108, plans for and timing of regulatory submissions, clearances and approvals, and clinical trial timing and potential efficacy readouts. 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 focused on the same or different indications; the Company's expected cash runway 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
