XenoPort, a biopharmaceutical company, has begun a Phase I clinical trial of XP23829, a novel fumarate analog for the potential treatment of relapsing-remitting multiple sclerosis and psoriasis.
The randomised, double-blind study, which is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829 in both fasted and fed conditions, has dosed the first subject.
XenoPort chief executive officer Ronald W Barrett said dosing of the first human subject with XP23829 is an important milestone in the development of the potential fumarate analog.
"One goal of this study is to verify that XP23829 is efficiently metabolised to produce MMF in the blood," Barrett added.
"We believe that the MMF pharmacokinetic profiles produced by the different XP23829 formulations administered with and without food will be instructive for the selection of one or more formulations to take forward into future trials."
The two-period, crossover food effect comparison study will assign approximately 60 healthy individuals to one of five cohorts with each cohort receiving one of four different formulations of XP23829 or placebo.
The four XP23829 formulations will include one immediate-release formulation and three extended-release formulations that are designed for possible once-a-day dosing of XP23829.
Subjects will be given a single dose of XP23829 or placebo in both a fasted and fed state in a randomised order and then the blood levels of XP23829, its active metabolite, monomethyl fumarate, and other potential metabolites will be assessed.
XP23829 is a fumaric acid ester compound which demonstrated a greater degree of efficacy compared to Dimethyl fumarate in preclinical animal models of both multiple sclerosis and psoriasis.
Image: Photomicrograph of a demyelinating MS lesion. Kluver-Barerra-Stain. Original magnification 10x. Photo: Marvin 101.