Palisade Bio receives Health Canada approval for Phase 1b trial of PALI-2108.

Palisade Bio has received a No Objection Letter from Health Canada for its Clinical Trial Application to evaluate PALI-2108, a first-in-class PDE4 B/D inhibitor, in a Phase 1b clinical study for fibrostenotic Crohn's disease (FSCD). Patient dosing is expected to commence in H2 2025, with topline data anticipated in Q1 2026. The company is also making progress toward Phase 2 IND submissions in Q1 2026.

Palisade Bio, Inc. (Nasdaq: PALI), a clinical-stage biopharmaceutical company focused on developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application to evaluate PALI-2108, a first-in-class PDE4 B/D inhibitor, in a Phase 1b clinical study for fibrostenotic Crohn's disease (FSCD) [1][2]. This clearance marks a significant milestone in the company's efforts to address the urgent and growing need for effective therapies for FSCD, a condition with no approved treatments.

The Phase 1b study, which will enroll approximately 6-12 patients, aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108. Patient dosing is expected to commence in the second half of 2025, with topline safety, PK, and PD data anticipated in the first quarter of 2026. The study will also explore exploratory endpoints such as histology, intestinal ultrasound, and patient-reported outcomes.

Palisade Bio's Chief Medical Officer, Dr. Mitchell Jones, 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."

The company is also making progress towards Phase 2 IND submissions in the first quarter of 2026, with data from this Phase 1b FSCD study and results from Palisade's completed Phase 1a/1b trials in ulcerative colitis supporting these submissions.

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, aiming to maximize anti-inflammatory and anti-fibrotic effects while reducing class-related tolerability issues.

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 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: 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.

References:
[1] https://www.stocktitan.net/news/PALI/palisade-bio-receives-health-canada-clearance-for-phase-1b-trial-of-ysq189vejsle.html
[2] https://www.globenewswire.com/news-release/2025/09/05/3145266/0/en/Palisade-Bio-Receives-Health-Canada-Clearance-for-Phase-1b-Trial-of-PALI-2108-in-Fibrostenotic-Crohn-s-Disease-FSCD.html