Safety, Pharmacokinetics, and Clinical Efficacy of ADS051, a Neutrophil Modulator, in Ulcerative Colitis: Results of a Randomized Phase 1b Trial.

ABSTRACT:

Introduction

Ulcerative colitis (UC) is characterized by colonic inflammation, with neutrophils playing a key role in UC activity, prognosis, and response to therapies. Current UC therapeutics can have significant side effects and limited efficacy. ADS051 is a novel, oral, gut-restricted small molecule that modulates neutrophil migration and activation without in vitro suppression of T-cell activation. The primary objective of this Phase 1b multidose trial was to evaluate the safety of ADS051. Secondary objectives were clinical activity and pharmacokinetics assessment.

Methods

This trial enrolled 24 patients with moderate-to-severe UC in 3 sequential ascending dose cohorts with 3:1 randomization to ADS051 200 mg, 800 mg, or 3,200 mg, or placebo, administered orally once dail

SUBMITTER: Allegretti JR 

PROVIDER: S-EPMC12208385 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature