Palisade Bio Granted Canadian Patent Covering Composition of Lead Product Candidate PALI-2108
Rhea-AI Summary
Palisade Bio (Nasdaq: PALI) announced that the Canadian Intellectual Property Office granted patent No. 3,174,137 for PALI-2108, titled “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors,” providing composition-of-matter protection through May 28, 2041. PALI-2108 is an orally administered, ileocolonic-targeted PDE4 B/D inhibitor designed for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC). The molecule uses a galactose-derived sugar moiety activated by colonic β-glucuronidase to enable colon-specific distribution with reduced systemic exposure, as shown in a tissue distribution study. Patient dosing in the Phase 1b FSCD study was expected in H2 2025, topline data expected in Q1 2026, and a planned Phase 2 IND submission to FDA is targeted for H1 2026.
Positive
- Patent protection secured through May 28, 2041
- Colon-targeted design via galactose-derived prodrug moiety
- Reduced systemic exposure demonstrated in tissue distribution study
- Phase 1b dosing for FSCD expected in H2 2025
Negative
- Efficacy and safety in FSCD not yet demonstrated in Phase 1b
- Topline clinical data not expected until Q1 2026
Insights
Grant of a Canadian composition patent strengthens exclusivity for PALI-2108 through
The patent gives Palisade Bio composition-of-matter protection in Canada for PALI-2108, which materially secures control of the molecule's core chemical identity in that jurisdiction. Composition claims are the strongest form of IP for small molecules because they block rivals from making the same active entity rather than only narrower formulation or use claims.
Key dependencies and risks include the geographic scope (Canada only), enforceability against any future analogs, and the remaining global patent estate not disclosed here; the patent term to
PALI-2108 advances clinically while IP protection now covers Canadian composition rights; dosing in Phase 1b expected in
PALI-2108 is described as an ileocolonic-targeted PDE4 B/D inhibitor designed for FSCD and UC using a galactose-derived prodrug activated by β-glucuronidase, with tissue distribution data cited to show localized activation and reduced systemic exposure. The clinical path shown includes Phase 1b patient dosing expected in
Dependencies and risks are the unknowns in clinical safety, efficacy, and regulatory review that are not detailed here; the press release gives timelines but no outcome data. Monitor the
PALI-2108 is the first and only PDE4 inhibitor designed to target terminal ileum and colon for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC) to address significant unmet medical needs
Carlsbad, CA, Oct. 13, 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 the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” The patent covers the composition of PALI-2108, the Company’s orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.
J.D. Finley, Chief Executive Officer of Palisade commented, “We remain committed to strengthening the intellectual property portfolio around PALI-2108 and are focused on advancing the development of this program. The granting of this patent marks an important addition to our global IP portfolio estate . Our team continues to execute on our clinical milestones, and we look forward to pursuing the full therapeutic promise of PALI-2108 to treat patients with FSCD and UC.”
The patent provides composition-of-matter protection for PALI-2108 through May 28, 2041. PALI-2108’s unique design incorporates a galactose-derived sugar moiety that allows for minimal absorption until converted by the colonic bacterium enzyme β-glucuronidase. This mechanism is intended to ensure localized bioactivation, leading to colon-specific distribution with reduced systemic exposure, as demonstrated in a tissue distribution study.
Palisade Bio continues to advance the development of PALI-2108 in its Phase 1b FSCD study with patient dosing expected to commence in H2 2025 and topline data expected in Q1 2026. Data from the FSCD Phase 1b, together with results from Palisade’s completed Phase 1a/1b trials in UC, 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 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 timing of clinical trials, the potential therapeutic benefits of PALI-2108, the expected duration and scope of patent protection, and plans for regulatory submissions. 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; 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.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com
Source: Palisade Bio
FAQ
What does Palisade Bio's Canadian patent for PALI-2108 cover and how long does it last?
How does PALI-2108 achieve colon-specific activation for PALI (Nasdaq: PALI)?
When will Palisade Bio start dosing patients in the Phase 1b FSCD study for PALI-2108?
When does Palisade Bio expect topline data from the PALI-2108 FSCD study?
What regulatory milestone does Palisade plan for PALI-2108 in 2026?
