Palisade Bio provided an update on its progress toward the launch of its Phase 1 human clinical study for PALI-2108 for the treatment of ulcerative colitis. The Company’s lead program, PALI-2108, is a locally activated PDE4 inhibitor prodrug in development for treating patients with moderate to severely active UC. Leveraging advanced machine learning, the Company’s research has identified a measurable threshold of elevated PDE4B expression across more than 1,600 patients and 10 studies, identifying over-expressing patients in over 70% of cases. This finding supports the potential for an FDA-approved test that uses PDE4B expression as a reliable marker for patient enrichment. The Company believes this will lead to better UC patient selection, thereby increasing the efficacy of Palisade’s PDE4-inhibiting prodrug therapeutic. Additionally, the Company is advancing a second approach featuring six PDE4-related biomarkers, which has demonstrated superior performance compared to benchmark tests and is specifically tailored for PDE4 inhibition, providing a targeted solution to improve therapeutic outcomes. The integration of PCR-based assays aimed at potential FDA approval will ensure precision in patient targeting
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