Palisade Bio announced that the Japan Patent Office has granted a composition‑of‑matter patent for its lead candidate PALI‑2108, a gut‑restricted phosphodiesterase‑4 (PDE4) inhibitor prodrug designed for ulcerative colitis and fibrostenotic Crohn’s disease. The patent, titled “Gut Microbiota‑Activated PDE4 Inhibitor Prodrug,” provides protection in Japan through 2041 and can be extended in line with regulatory review timelines.
The grant extends Palisade’s intellectual‑property moat in a market that the company identifies as one of the world’s largest for inflammatory bowel disease (IBD). By securing exclusive rights to the prodrug’s unique activation mechanism, the company can protect its precision‑delivery platform from competitors and secure a first‑mover advantage in Japan, a key growth region for IBD therapies.
PALI‑2108 has completed Phase 1a studies, including single‑ascending, multiple‑ascending, and food‑effect cohorts, and a Phase 1b cohort in ulcerative colitis patients. An ongoing Phase 1b study in fibrostenotic Crohn’s disease is underway, and Palisade plans to file a Phase 2 investigational new drug application with the U.S. Food and Drug Administration in the first half of 2026. The patent grant therefore dovetails with the company’s clinical roadmap and regulatory strategy.
CEO J.D. Finley said the Japanese patent “is an important milestone as we continue to strengthen the IP foundation for our IBD portfolio” and added that “Japan represents one of the world’s largest and most commercially significant markets for inflammatory bowel disease.” He emphasized that the patent “reinforces the global reach of our technology and supports the long‑term opportunity of PALI‑2108 as a differentiated, locally‑acting therapy.”
Analysts have responded positively to the patent announcement, citing the strong clinical data from the Phase 1b ulcerative colitis cohort and the strategic value of the IP in Japan. Coverage has been initiated by several research firms, reflecting confidence in Palisade’s precision‑delivery platform and the potential for a robust market entry in a high‑need therapeutic area.
The patent grant, combined with the company’s clinical progress and planned Phase 2 filing, positions Palisade to advance its IBD pipeline while protecting its technology in a critical market. The move strengthens investor confidence in the company’s long‑term commercialization prospects and underscores the strategic importance of securing robust IP for its next‑generation therapeutics.
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