Ongoing PALI-2108 Ulcerative Colitis Phase 1a/b Study

PALI-2108
Ongoing Ulcerative Colitis Phase 1a/b Study

Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of PALI-2108 in Healthy Volunteers and Open-Label Study of a Patient Cohort With Ulcerative Colitis

On track to report topline data in first half of 2025

Single Ascending Dose (n~40)

  • Primary Endpoint: Safety and tolerability
  • Secondary Endpoints: PK including Tmax, Cmax and T1/2

Multiple Ascending Dose (n~32)

  • Primary Endpoint: Safety and tolerability
  • Secondary Endpoints: PK including plasma and tissue C SS and colon : plasma ratio

Multiple Dose UC Cohort (n~6)

  • Pharmacokinetic Endpoints: Plasma, colon tissue, urine, stool including plasma and tissue C SS and colon : plasma ratio
  • Pharmacodynamic Endpoints: Fecal calpro, calpro epitope, hsCRP, colon tissue PDE4s, cAMP, TLC and histology

Preliminary Data

Positive preliminary data from all five single ascending dose (SAD) cohorts and first three completed multiple ascending dose (MAD) cohorts support safety and tolerability of PALI-2108.

No serious adverse events (SAEs) and no treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs seen to date.

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.

Clinical Trials: NCT06663605

PDE4 Platform

Precision Medicine Approach

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