Palisade Bio Provides Update on Progress Toward Launch of Phase 1 Human Clinical Study for Lead Program for the Treatment of Ulcerative Colitis

Palisade Bio, Inc. recently 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 progress of our PALI-2108 program. UC represents a significant challenge for patients who need therapies that provide effective remission rates, are non-immunosuppressive, and have improved safety profiles. Our team continues to execute on the clinical and regulatory steps necessary for the launch of our Phase 1 study and remains confident in our timeline to initiate before year-end,” said Dr. Mitch Jones, CMO of Palisade Bio.

The company has submitted a CTA for its Phase 1 study of PALI-2108, which will be a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. As previously announced, the company has established dose levels and trial design for PALI-2108 and plans to enroll approximately 90 patients across the SAD, FE, MAD and UC cohorts. The primary objective of the study is to assess the safety and tolerability of single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses of PALI-2108. Secondary objectives include determining the plasma, urinary, and fecal (MAD healthy subjects and UC patients only) pharmacokinetics (PK) of PALI 2108 and its metabolites (PALI-0008 and PALI-0708) following PALI-2108 single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses, as well as the effect of food on the PK of PALI-2108 and its metabolites (PALI-0008 and PALI-0708; if applicable) following a single oral dose in healthy subjects.

Additionally, the company recently held a pre-CTA consultation meeting with Health Canada with the objective of presenting its SAD-MAD-FE Phase 1 program in normal healthy volunteers for PALI-2108. Palisade believes it achieved its objective of understanding Health Canada’s expectations and regulations governing clinical study design, which assisted in the submission of the CTA to commence the company’s Phase 1 study.

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, visit www.palisadebio.com.