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Highlights

  • Palisade Bio completes enrollment and dosing in Phase 1a and 1b portions of PALI-2108 trial
  • Preliminary results show no serious adverse events (SAEs) or major lab-related issues
  • Company remains on track to report topline Phase 1a data by May 2025

Palisade Bio, Inc. (NASDAQ: PALI), a clinical-stage biopharmaceutical company focused on autoimmune, inflammatory, and fibrotic diseases, has announced the completion of enrollment and dosing across multiple cohorts in its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC). This includes the completion of all five Phase 1a single ascending dose (SAD) cohorts, all four multiple ascending dose (MAD) cohorts, and a food effects crossover within the Phase 1a portion of the trial.

Preliminary results from the study show that there have been no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) linked to laboratory values or EKGs. The majority of observed TEAEs were mild, with only one withdrawal occurring in the highest 50 mg twice-daily (BID) MAD cohort. Several MAD cohorts, ranging from 15 mg BID to 30 mg BID, were completed within the expected therapeutic dose range, again showing no significant safety concerns. The 15 mg BID cohort had no TEAEs, while the 30 mg BID cohort experienced a single mild TEAE.

PALI-2108, a highly potent PDE4 inhibitor, has shown excellent tolerability in preclinical studies compared to other PDE4 inhibitors. The preliminary results indicate that the drug is well-tolerated at therapeutic dose levels, supporting its potential for use in UC treatment.

Screening and dosing for the Phase 1b UC patient cohort are ongoing, with one subject having completed this phase of the study. The company expects to report topline data from the Phase 1a portion by the end of May 2025. Dr. Mitch Jones, Chief Medical Officer of Palisade Bio, expressed confidence in the progress of the study, highlighting that the data supports the potential of PALI-2108 as a promising treatment for UC.