Palisade Bio Receives Health Canada Clearance for Phase 1b Trial of PALI-2108 in Fibrostenotic Crohn’s Disease (FSCD)

First dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition with no approved therapies

Patient dosing expected to commence in H2 2025; Topline data anticipated in Q1 2026

Continued progress toward Phase 2 IND submissions in Q1 2026

Carlsbad, CA, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced that it received a No Objection Letter ("NOL") from Health Canada for its Clinical Trial Application to evaluate PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor, in a Phase 1b clinical study for the treatment of fibrostenotic Crohn’s disease (FSCD).

Up to half of Crohn’s disease patients develop FSCD over the course of their illness, and there are currently no approved anti-fibrotic therapies. Current standards of care—including corticosteroids, endoscopic balloon dilation, and surgery—primarily address symptoms but fail to alter the fibrotic disease process, with many patients requiring repeated interventions or resections.

The open-label Phase 1b study will enroll approximately 6-12 patients to evaluate:

• Safety and tolerability through adverse event monitoring, labs, and EKGs;
• Pharmacokinetics (PK) in plasma and intestinal tissues (ileum, ascending and descending colon);
• Pharmacodynamics (PD) including paired ileal biopsies analyzed by RNA sequencing; and
• Exploratory endpoints such as histology, intestinal ultrasound (IUS), and patient-reported outcomes.

Dosing is expected to begin in the second half of 2025, with topline safety, PK, and PD readouts anticipated in the first quarter of 2026.

Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, commented, “This Health Canada clearance marks an important milestone for PALI-2108 as the first dual anti-inflammatory and anti-fibrotic therapy in development for FSCD. Our preclinical and clinical data demonstrate that PALI-2108 is ileum and colon targeted and locally bioactivated, safe, and well tolerated, while showing robust antifibrotic activity alongside potent anti-inflammatory effects. We believe this differentiated profile positions PALI-2108 addresses the urgent and growing need for therapies that go beyond symptom management to alter the course of FSCD. Our team is now focused on initiating patient dosing in the coming months and advancing toward Phase 2.”

Data from this Phase 1b FSCD study, together with results from Palisade’s completed Phase 1a/1b trials in ulcerative colitis, will support the Company’s planned Phase 2 IND submission to the U.S. Food and Drug Administration (FDA) in the first half of 2026.

About PALI-2108

PALI-2108 is an orally administered prodrug engineered for gut-restricted delivery of PDE4 B/D inhibition to the terminal ileum and colon. Activated by bacterial enzymes in the lower intestine, PALI-2108 achieves high local tissue concentrations while minimizing systemic exposure. This design aims to maximize anti-inflammatory and anti-fibrotic effects while reducing class-related tolerability issues such as nausea and headache that have historically limited systemic PDE4 inhibitors.

About Palisade Bio

Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to .

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: statements regarding the safety and tolerability, PK and drug release characteristics, potential clinical efficacy and dosing requirements of PALI-2108 based on the Company’s preclinical studies and data from its Phase 1a/b clinical study; indications and anticipated benefits of PALI-2108, including the potential of PALI-2108 to treat FSCD; and the expected timing of the Company’s planned Phase 1b clinical study of PALI-2108 for the treatment of FSCD. 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, activity, dosing or durability of effect, observed from preclinical or clinical trials, 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 Company’s ability to secure additional financing to fund future operations and development of its product candidates; 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, 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.

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