- The Phase 1a trial of PALI-2108 met all primary endpoints, demonstrating positive safety and tolerability outcomes.
- No serious adverse events were observed, with the drug achieving therapeutic colon concentrations with minimal systemic exposure.
- Palisade Bio plans to advance PALI-2108 into a Phase 1b cohort and is preparing for Phase 2 clinical programs.
Palisade Bio (PALI, Financial) has reported successful Phase 1a results for its novel drug, PALI-2108, aimed at treating fibrostenotic Crohn's disease and ulcerative colitis. The study met its primary endpoints, highlighting a favorable safety profile, alongside promising tolerability and pharmacokinetic (PK) results.
A key finding from the trial was the absence of serious adverse events (SAEs) across both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Only mild and reversible treatment-emergent adverse events (TEAEs) were noted at higher doses, with one moderate event at a 50mg BID dose leading to patient withdrawal. The 15mg BID dose, crucially, presented no treatment-emergent adverse events.
Pharmacokinetic analysis revealed that PALI-2108 achieved therapeutically relevant concentrations in colon tissue up to 24 hours post-dose, while maintaining low systemic exposure. This targeted delivery to the terminal ileum and colon is a significant advancement for a PDE4 inhibitor, aimed at minimizing off-target effects.
The positive results support the progression of PALI-2108 to a Phase 1b cohort in fibrostenotic Crohn’s disease patients, with plans to quickly follow up with Phase 2 clinical programs. These future studies aim to evaluate PALI-2108's efficacy, safety, and tolerability in a broader patient population suffering from inflammatory bowel diseases.
Palisade Bio, based in Carlsbad, CA, continues to push forward with its clinical-stage biopharmaceutical developments, focusing on advancing novel therapies for autoimmune and inflammatory diseases.
