Palisade Bio Completes Dosing in Phase 1a Portion of Ongoing Phase 1a/b Study of PALI-2108

Palisade Bio, Inc. recently announced the completion of enrollment and dosing in all five Phase 1a SAD cohorts, all four MAD cohorts, and the food effects crossover in the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

Preliminary results show no SAEs and no TEAEs related to laboratory values or EKGs to date. The majority of observed TEAEs were considered mild, with only a single withdrawal in the highest 50 mg twice-daily dosage (BID) MAD cohort. Several of the MAD cohorts, ranging from 15 mg BID to 30 mg BID, were completed within the expected therapeutic dose range, again showing no SAEs or TEAEs related to laboratory values or EKGs. The 15 mg BID cohort was completed with no TEAEs, while the titrated 30 mg BID cohort was completed with a single mild TEAE. Given PALI-2108’s high potency towards PDE4 B and D compared to other PDE4 inhibitors in preclinical studies, these results underscore its excellent tolerability at comparable dose levels. Screening and dosing of the Phase 1b UC patient cohort are ongoing, with one subject having completed this portion of the study. The Company is on track to report topline data from the Phase 1a portion of the study by the end of May 2025.

“We continue to make significant progress in our Phase 1a/b study of PALI-2108. With the completion of the Phase 1a portion and our ongoing efforts in screening, enrollment, and dosing within the Phase 1b cohort of UC patients, we remain on track to report topline data in the first half of 2025. Preliminary results from both our SAD and MAD cohorts support our confidence that we are dosing at the target therapeutic levels without encountering significant adverse events. This further strengthens our belief that PALI-2108 has the potential to offer a much-needed treatment option for patients with UC. We remain focused on the successful execution of the trial and look forward to sharing full topline data in the near future,” 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.

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.