Palisade Bio Completes All Five SAD Cohorts & Advances to MAD Cohorts of Phase 1a/b Study of PALI-2108 for Treatment of Ulcerative Colitis

Palisade Bio, Inc recently 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 report topline data in the first half of 2025.”

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 can transform the treatment landscape. For more information, visit www.palisadebio.com.