- 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
Palisade Bio, Inc. (PALI, Financial), a clinical-stage biopharmaceutical company from Carlsbad, has announced the successful completion of dosing in the Phase 1a portion of its ongoing Phase 1a/b study for PALI-2108, a treatment for Ulcerative Colitis (UC). This marks a significant milestone as the company progresses towards the development of this novel therapeutic.
The study encompassed five Single Ascending Dose (SAD) cohorts, four Multiple Ascending Dose (MAD) cohorts, and a food effects crossover. Preliminary results indicated promising safety data with no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs. The majority of observed TEAEs were mild, with only a single withdrawal in the highest 50mg twice-daily dosage (BID) MAD cohort.
Several MAD cohorts, ranging from 15mg BID to 30mg BID, were completed within the expected therapeutic dose range, showing excellent tolerability. The 15mg BID cohort was completed with no TEAEs, while the 30mg BID cohort reported a single mild TEAE.
Currently, Palisade Bio is screening and dosing patients for the Phase 1b UC cohort, with one subject having completed this portion. Topline data from the Phase 1a study is expected by May 2025, with complete Phase 1a/b results anticipated in the first half of 2025. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of PALI-2108 in both healthy volunteers and UC patients.
Palisade Bio's investigation involves the use of several biomarkers such as serum high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), colonic tissue histology, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, and Absolute Lymphocyte Count to further assess the drug's effects and efficacy.
The successful completion of the Phase 1a portion marks an encouraging step for Palisade Bio, keeping the program on track and fortifying hopes for the treatment's potential in addressing unmet needs in UC patients.
