Palisade Bio Announces First Subject Dosed in Phase 1 Study for Moderate-to-Severe Ulcerative Colitis Treatment

Palisade Bio, Inc. recently announced it dosed its first subject in its Phase 1 clinical study of PALI-2108, an orally administered PDE4 inhibitor prodrug that is locally bioactivated in the colon and is in development for patients affected by UC.

The Phase 1 study will evaluate PALI-2108 in 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. Patient screening for the study is underway.

“The dosing of our first subject marks an important milestone as Palisade transitions to a clinical stage company. We anticipate releasing topline data during the first half of 2025,” said JD Finley, Chief Executive Officer of Palisade Bio.

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 pharmacokinetics (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. The study will consist of single ascending dose (SAD) cohorts followed by a 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. 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. For more information about the Phase 1 clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

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.