Palisade Bio Announces Preliminary Data From Phase 1 Clinical Study for the Treatment of Moderate-to-Severe Ulcerative Colitis Appears to be Safe & Well Tolerated

Palisade Bio, Inc recently announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for PALI-2108 for the treatment of Ulcerative Colitis (UC).

The ongoing Phase 1 study is evaluating PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers, alongside an open-label study involving a patient cohort with UC.

Preliminary results appear to indicate that PALI-2108 was safe and well tolerated in the first three cohorts (n=24; 6:2 active to placebo) at 15mg, 50mg, and 150mg, with no treatment related dose reductions, no Treatment Related Adverse Events (TRAEs), no Serious Adverse Events (SAEs), and no treatment related lab abnormalities in any subject. Preliminary PK data from the first cohorts demonstrated delayed release of the PDE4 inhibitor active suggesting PALI-2108 is performing as designed with colonic bioactivation. Based on the findings with this preliminary safety data, the Company is advancing towards its planned crossover study to evaluate the effects of food on PK, followed by multiple ascending dose (MAD) cohorts, and finally a multiple dose cohort of patients with UC. Comprehensive safety monitoring and similar PK evaluations will be conducted in this cohort.

The primary aim of this single-center Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of PALI-2108 in healthy volunteers as well as to evaluate the safety, tolerability, and PK, and pharmacodynamics PD in patients with UC. Several PDE4 inhibitors have received market approval in both inflammatory and fibrotic disease; however, PALI-2108 represents a new chemical entity that has not been previously administered to humans. Biomarkers, including serum high sensitivity C-reactive protein (hsCRP), and fecal calprotectin (CalPro), along with colonic tissue histological assessments, will be employed to provide further insights into the drug’s effects. The analysis of colon tissue will include the study drug and metabolite levels, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, Absolute Lymphocyte Count (ALC), and related PD biomarkers, which are crucial for understanding the drug’s mechanism and efficacy.

The company is on track to report topline data from this study in the first half of 2025. For more information about the Phase 1 clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. It is anticipated that the comprehensive data gathered will support Palisade Bio’s precision medicine strategy, aimed at identifying patient responders for future clinical studies.

Palisade Bio is a clinical-stage 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.