Palisade Bio Commences Dosing in First Ulcerative Colitis Patient Cohort in Ongoing Phase 1a/b Study of PALI-2108

Palisade Bio, Inc. recently provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

The Company has commenced dosing of the first UC patient in the final cohort of its Phase 1a/b study of PALI-2108. In addition to completing the five previous Phase 1a SAD cohorts, the first three of four MAD cohorts have now been completed. Importantly, there have been no SAEs and no TEAEs related to laboratory values or EKGs. The majority of observed TEAEs were considered mild, with a single withdrawal at the highest MAD dose level. Two of the MAD cohorts were completed within the expected therapeutic dose range, again showing no SAEs or TEAEs related to laboratory values or EKGs. One of these cohorts was completed with no TEAEs, underscoring the excellent tolerability of PALI-2108 at these dose levels.

“We are pleased with the initiation of the final MAD and UC cohorts in our Phase 1a/b study of PALI-2108. Of particular note is our successful transition from healthy volunteers to dosing our first cohort of patients with UC. The preliminary results from our SAD and MAD cohorts align with management’s expectations. We look forward to further evaluations, and we remain on track to report topline data in the first half of 2025,” said Dr. Mitch Jones, Chief Medical Officer of Palisade.

The primary aim of this single-center Phase 1a/b study is to evaluate the safety, tolerability, and PK of PALI-2108 in healthy volunteers as well as to evaluate the safety, tolerability, 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.

For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

About Palisade Bio

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, please go to www.palisadebio.com.