Palisade Bio Receives FDA Clearance of IND for PALI-2108 in Crohn’s Disease, Expanding Phase 2 Development Across IBD
FDA clearance lets Palisade Bio advance oral PDE4 prodrug PALI-2108 into Phase 2 trials in both ulcerative colitis and Crohn’s disease.
Rhea-AI Summary
Palisade Bio (PALI) received FDA clearance of its Investigational New Drug application for PALI-2108 in moderate to severe Crohn’s disease, enabling initiation of the Phase 2 ASCENTRA-CD trial.
ASCENTRA-CD is a multicenter, open-label, single-arm study in approximately 60 adults, with a 14-day dose titration to 30 mg once-daily oral PALI-2108, followed by a 12-week induction and 36-week maintenance phase. The primary endpoint is Week 12 endoscopic response, defined as at least a 50% reduction from baseline in SES-CD by blinded central review, with multiple clinical and endoscopic secondary endpoints through Week 48. First patient dosing is targeted for Q1 2027 and the primary efficacy readout for Q1 2028. The program builds on prior clinical experience in fibrostenotic Crohn’s disease and, together with the ASCENTRA-UC study, is intended to create a broader Phase 2 dataset across inflammatory bowel disease.
Positive
- FDA IND clearance for PALI-2108 in Crohn’s disease enables Phase 2 ASCENTRA-CD trial.
- ASCENTRA-CD planned to enroll ~60 patients with moderate to severe Crohn’s disease.
- Trial includes 12-week induction and 36-week maintenance phases with once-daily oral dosing.
- Primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028.
- Phase 2 development now advancing in both ulcerative colitis and Crohn’s disease for PALI-2108.
Negative
- None.
Details
Market Reaction – PALI
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Key Figures
- IND status
- FDA cleared
- PALI-2108 Phase 2 ASCENTRA-CD trial
- Planned enrollment
- approximately 60 patients
- Moderate to severe Crohn’s disease
- First patient dosing
- Q1 2027
- ASCENTRA-CD Phase 2 study
- Primary efficacy readout
- Q1 2028
- ASCENTRA-CD Phase 2 study
- Target dose
- 30 mg once daily
- Oral PALI-2108 after dose titration
- Dose titration
- 14 days
- ASCENTRA-CD trial design
- Primary endpoint
- at least a 50% reduction from baseline
- Week 12 endoscopic response measured by SES-CD
- Study duration
- 12-week induction and 36-week maintenance
- ASCENTRA-CD Phase 2 study
Previous Clinical trial,fda approval Reports
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FDA clearance enabled Phase 2 ASCENTRA-UC in ulcerative colitis with planned enrollment and readout.
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Key Terms
pde4 medical
pharmacokinetics technical
pharmacodynamics technical
ses-cd medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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
Attachment
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is the design of the ASCENTRA-CD Phase 2 trial?
ASCENTRA-CD is a multicenter, open-label, single-arm Phase 2 study evaluating efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in approximately 60 adults with moderate to severe Crohn’s disease. Patients undergo a 14-day dose titration to a target dose of 30 mg orally once daily, followed by a 12-week induction phase and a 36-week maintenance phase, for a total of 48 weeks of treatment and assessment.
What is the primary endpoint of ASCENTRA-CD?
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.
What key secondary endpoints will be evaluated in the ASCENTRA-CD trial?
Key secondary endpoints at Week 12 include clinical remission, endoscopic remission, PRO-2 remission (abdominal pain and stool frequency), clinical response, and a combined endpoint of clinical remission and endoscopic response, with additional maintenance assessments through Week 48.
When are the first patient dosing and primary efficacy readout expected for ASCENTRA-CD?
The company anticipates first patient dosing in Q1 2027 and a primary efficacy readout for the Week 12 endoscopic response endpoint in Q1 2028.
How does ASCENTRA-CD relate to Palisade Bio’s broader PALI-2108 program?
ASCENTRA-CD is designed to extend prior PALI-2108 findings in fibrostenotic Crohn’s disease into a broader moderate to severe Crohn’s population using centrally read endoscopic response at Week 12 as the primary endpoint. Together with the ASCENTRA-UC study in ulcerative colitis, it is intended to generate a broader Phase 2 dataset on the efficacy, safety and pharmacology of PALI-2108 across the two major forms of inflammatory bowel disease.