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Palisade Bio Provides Update on Progress Toward Launch of Phase 1 Human Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis
– Completion of nonclinical safety and toxicity studies, Phase 1 clinical trial design and established Maximum Recommended Starting Dose – Completion of pre-
About this update from Palisade Bio, Inc.
[{"type":"text","content":"– Completion of nonclinical safety and toxicity studies, Phase 1 clinical trial design and established Maximum Recommended Starting Dose – Completion of pre- Clinical Trial Application (CTA) meeting with Health Canada – Submission of the CTA for the Phase 1 clinical study of Normal Healthy Volunteers and ulcerative colitis patients – On track towards clinical site initiation and dosing of first patient in Phase 1 human clinical study before year end Carlsbad, CA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today 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 (UC). 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. These developments underscore the Company’s commitment to leading the field of precision medicine for UC, advancing personalized treatment strategies that promise to transform patient care. “We are excited to announce significant progress in our development of precision medicine tests designed to optimize treatment for moderate to severely active UC patients. We are also pleased with the continued pr...