Palisade Bio Announces Completion Of Dosing In Phase 1a Portion Of Ongoing Phase 1a/b Study Of PALI-2108 For Treatment Of Ulcerative Colitis

Sustained positive preliminary data from all completed single ascending dose (SAD) cohorts, multiple ascending dose (MAD) cohorts, and food effects crossover, further supporting the safety and tolerability of PALI-2108

No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs observed to date

Screening for Phase 1b UC cohort ongoing; On track to report topline data in the first half of 2025

Carlsbad, CA, April 09, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade", "Palisade Bio", or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases, today 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.