ASCENTRA-CD expected to enroll approximately 60 patients with moderate to severe Crohn's disease
First patient dosing targeted for Q1 2027; primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028
Phase 2 program builds on clinical experience in fibrostenotic Crohn's disease demonstrating targeted tissue exposure, PDE4 target engagement and encouraging endoscopic activity
Denver, CO, Sept. 22, 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 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 Phase 2 ASCENTRA-CD clinical trial in patients with moderate to severe Crohn's disease (CD).
"FDA clearance of the ASCENTRA-CD IND marks another significant milestone for PALI-2108 and meaningfully expands our Phase 2 development program across inflammatory bowel disease," said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. "Crohn's disease remains a progressive condition where many patients experience inadequate response or loss of response to existing therapies. We believe PALI-2108's differentiated prodrug design, once-daily oral dosing and targeted activation within the ileum and colon provide a compelling foundation for development in this population. Importantly, we enter Phase 2 with direct clinical experience demonstrating favorable tolerability, targeted tissue exposure, PDE4 target engagement and encouraging early biological and endoscopic activity."
ASCENTRA-CD Phase 2 Trial Design
ASCENTRA-CD is a multicenter, open-label, single-arm Phase 2 study designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in approximately 60 adults with moderate to severe Crohn's disease. Patients will undergo a 14-day dose titration to the target dose of PALI-2108 30 mg orally once daily. The study includes a 12-week induction phase followed by a 36-week maintenance phase.
The primary endpoint is endoscopic response at Week 12, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD), based on blinded central endoscopic review. Key secondary endpoints at Week 12 include clinical remission, endoscopic remission, PRO-2 remission (a patient-reported outcome of abdominal pain and stool frequency), clinical response and combined clinical remission and endoscopic response, with additional maintenance assessments through Week 48.
The Company anticipates first patient dosing in Q1 2027, and a primary efficacy readout in Q1 2028.
PALI-2108 in Crohn's Disease
Crohn's disease is a chronic, progressive inflammatory condition in which persistent or recurrent inflammation can lead to irreversible tissue remodeling, fibrosis and bowel disability.
PALI-2108 is designed to address these challenges through an oral, locally activated prodrug approach. Following oral administration, the drug is activated in the terminal ileum and colon, generating high local intestinal exposure while also supporting sustained systemic exposure and a differentiated pharmacokinetic profile. PALI-2108 has already been evaluated in patients with fibrostenotic Crohn's disease, providing direct clinical experience with ileal and colonic tissue exposure, PDE4 target engagement and endoscopic activity. ASCENTRA-CD is designed to extend those findings into a broader moderate to severe Crohn's disease population using centrally read endoscopic response at Week 12 as the primary endpoint.
With Phase 2 development now advancing in both ulcerative colitis and Crohn's disease, Palisade is advancing a broad clinical development program for PALI-2108 across the two major forms of inflammatory bowel disease. Together, ASCENTRA-UC in ulcerative colitis and ASCENTRA-CD in Crohn's disease are designed to generate a broader clinical dataset around the efficacy, safety and pharmacology of PALI-2108.
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
PALI@jtcir.com
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