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Palisade Bio Completes All Five SAD Cohorts and Advances to MAD Cohorts of Phase 1a/b Study of PALI-2108 for Treatment of Ulcerative Colitis
Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to
About this update from Palisade Bio, Inc.
[{"type":"text","content":"Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 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 autoimmune, inflammatory and fibrotic diseases, today announced the completion of all five planned Single Ascending Dose (SAD) cohorts and the commencement of the Multiple Ascending Dose (MAD) cohorts in its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC). Preliminary data from the SAD portion of the study, which evaluated doses ranging from 15 mg to 450 mg of PALI-2108, support that the drug was well-tolerated across all dose levels. Importantly, there were no treatment-related dose reductions, serious adverse events (SAEs), or treatment-related laboratory abnormalities observed. Treatment-emergent adverse events (TEAEs) were mild and occurred only at the highest dose of 450 mg. Importantly, there were no EKG abnormalities or other serious safety concerns, underscoring the favorable safety profile of PALI-2108. In addition to its safety and tolerability, preliminary pharmacokinetic (PK) analysis from the SAD portion of the study showed the delayed-release and extended-release characteristics of PALI-2108, which provides sustained, dose-dependent drug exposure with high local concentrations in the colon, a key feature for the targeted treatment of UC. This preliminary data provides strong support for the ongoing MAD portion of the trial, which aims to assess repeat dosing and further evaluate the safety and pharmacokinetics of PALI-2108 in both healthy volunteers and UC patients. “We are excited to move from the SAD to the MAD portion of our Phase 1a/b study of PALI-2108, a significant milestone that brings us one-step closer to delivering an innovative, safe, and effective treatment option for UC patients,” said Dr. Mitch Jones, Chief Medical Officer of Palisade. “The preliminary data from the SAD cohorts have reinforced our confidence in PALI-2108’s safety profile, and we remain on track to rep...