Palisade Bio Receives Canadian Patent Approval for PALI-2108

Palisade Bio, Inc., a biopharmaceutical company specializing in novel treatments for autoimmune, inflammatory, and fibrotic diseases, has announced a significant milestone. The Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for the company's patent application number 3,174,137. This patent, titled “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors,” covers the composition of PALI-2108. PALI-2108 is an orally administered, colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug currently under development for treating Ulcerative Colitis (UC).

J.D. Finley, the Chief Executive Officer of Palisade Bio, expressed his satisfaction with this development, emphasizing the company's commitment to strengthening its intellectual property portfolio around PALI-2108. He noted that this is the first patent notice of allowance for the composition of matter for PALI-2108 and allows the company to establish and build upon a patent family in various geographies. Finley highlighted the potential of PALI-2108 to become the first approved PDE4 inhibitor for UC, describing it as a next-generation therapeutic option for patients with inflammatory bowel disease.

The allowed patent claims encompass the proprietary composition of PALI-2108. Preclinical studies have shown encouraging results. In a DSS-induced UC mouse model, PALI-2108 demonstrated a significant reduction in disease activity index (DAI) score over time when compared to a control group. Additionally, certain dosage groups exhibited reduced body weight loss, indicating targeted efficacy. PALI-2108's unique design includes a galactose-derived sugar moiety, which allows for minimal absorption until it is cleaved by the colonic bacterium enzyme β-glucuronidase. This mechanism ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure, as confirmed by a tissue distribution study.

Palisade Bio is advancing PALI-2108 towards a Phase 1 clinical study for moderate-to-severe UC, which is anticipated to begin before the end of 2024.

Palisade Bio is dedicated to developing innovative therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases. The company's targeted approach aims to transform the treatment landscape for these conditions.