Palisade Bio, Inc. is moving forward with its lead program, PALI-2108, a locally activated PDE4 inhibitor prodrug, for the treatment of moderate to severely active ulcerative colitis (UC). The company anticipates initiating a Phase 1 human clinical study before the end of the year.
The Phase 1 study is designed as a single-center, double-blind, placebo-controlled trial. It will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in both healthy volunteers and a cohort of patients with UC. Approximately 90 patients are planned for enrollment across single ascending dose (SAD), food effect (FE), multiple ascending dose (MAD), and UC cohorts. The primary endpoint is the assessment of safety and tolerability, while secondary endpoints include pharmacokinetic profiling of PALI-2108 and its metabolites.
Precision Medicine Approach
Palisade Bio is employing a precision medicine approach to enhance the efficacy of PALI-2108. Research has identified elevated PDE4B expression in over 70% of UC patients across multiple studies. The company is developing PCR-based assays aimed at potential FDA approval to identify patients most likely to benefit from PDE4 inhibition. This strategy includes a second approach featuring six PDE4-related biomarkers, which has demonstrated superior performance compared to benchmark tests.
Regulatory Progress
Palisade Bio has completed a pre-CTA meeting with Health Canada and has submitted the CTA for the Phase 1 clinical study of PALI-2108. This progress underscores the company's commitment to advancing personalized treatment strategies for UC patients.
Unmet Need in Ulcerative Colitis
Ulcerative colitis presents a significant challenge, with many patients needing therapies that provide effective remission, are non-immunosuppressive, and have improved safety profiles. PALI-2108 aims to address these unmet needs through its targeted mechanism of action and precision medicine approach.
"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," commented Dr. Mitch Jones, CMO of Palisade Bio.
