Carlsbad, CA — December 30, 2025 — Leads & Copy —Palisade Bio, Inc. (Nasdaq: PALI) announced that the Japan Patent Office (JPO) has granted a key patent covering PALI-2108, the company’s lead, gut-microbiota-activated PDE4 B/D inhibitor being advanced for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).
PALI-2108 is the first and only PDE4 inhibitor in development targeting the terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs. The company plans a Phase 2 IND submission for H1 2026.
The patent, titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug,” provides composition-of-matter protection for PALI-2108 in Japan. The base patent term extends into 2041 and is eligible for patent term extension based on regulatory review timelines. This issuance expands Palisade Bio’s growing global intellectual property estate supporting PALI-2108 and its broader platform of locally activated PDE4 inhibitor prodrugs.
According to J.D. Finley, Chief Executive Officer of Palisade Bio, securing this Japanese patent for PALI-2108 is an important milestone as the company continues to strengthen the IP foundation for its IBD portfolio. He added that Japan represents one of the world’s largest and most commercially significant markets for inflammatory bowel disease, and patients with UC and FSCD continue to face limited targeted treatment options.
Finley believes that the patent reinforces the global reach of their technology and also supports the long-term opportunity of PALI-2108 as a differentiated, locally-acting therapy with the potential to meaningfully improve outcomes for IBD patients in Japan and worldwide.
PALI-2108 has recently completed a Phase 1a SAD/MAD and FE, followed by a Phase 1b cohort study in UC and is currently being evaluated in an ongoing Phase 1b cohort study in FSCD. Data from these studies are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
PALI-2108 is an orally administered prodrug engineered for local delivery of phosphodiesterase-4 (PDE4) inhibition to the terminal ileum and colon. The prodrug molecule is gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is cleaved by bacterial enzymes to release its active PDE4 inhibitor metabolite directly at the site of inflammation and fibrosis.
This targeted and slow-release design prevents absorption through the upper gut, achieves sustained local exposure and a longer half-life that enables once-daily dosing, and is engineered to produce a blunted peak plasma concentration to improve the overall therapeutic index. Together, these properties are intended to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure and reducing class-related tolerability issues, such as nausea and headache, that have limited systemic PDE4 inhibitors.
Palisade Bio, Inc. (Nasdaq: PALI) is a clinical-stage biopharmaceutical company advancing a next generation of, once daily, oral PDE4 inhibitor prodrugs designed to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases. Through its differentiated prodrug platform and precision pharmacology strategy, Palisade Bio is committed to transforming proven PDE4 biology into better, safer oral therapies for patients living with chronic inflammatory and fibrotic diseases.
The company’s lead program, PALI-2108, is a locally-bioactivated PDE4 inhibitor prodrug being developed for moderate-to-severe Ulcerative Colitis (UC) and Fibrostenotic Crohn’s Disease (FSCD), two diseases with limited non-immunosuppressive therapy options. In a recently reported Phase 1b trial, PALI-2108 achieved a 100% clinical response in the UC cohort, with no serious adverse events, favorable tolerability and pharmacokinetics consistent with sustained localized activation, low systemic exposure, and controlled release within the GI tract.
Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission, response and pharmacodynamic biomarkers over 12 weeks, with an extension phase assessing maintenance of remission. In addition, the company is preparing to initiate studies in FSCD to further characterize PALI-2108’s safety, pharmacology and therapeutic benefit across inflammatory bowel disease indications.
Investor Relations Contact:
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com
Source: Palisade Bio
