Physiologically based pharmacokinetics (PBPK)

P Espié, D Tytgat, ML Sargentini-Maier… - Drug metabolism …, 2009 - Taylor & Francis
Allometric scaling is widely used to predict human pharmacokinetic parameters from preclinical
species, and many different approaches have been proposed over the years to improve …

Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjögren's syndrome: a multicentre, randomised, double-blind, placebo-controlled, proof-of …

…, F Barone, SJ Bowman, P Espié… - The Lancet …, 2020 - thelancet.com
Background Primary Sjögren's syndrome is an autoimmune disease that presents as dryness
of the mouth and eyes due to impairment of the exocrine glands. To our knowledge, no …

Pharmacokinetics and metabolism of 14C-brivaracetam, a novel SV2A ligand, in healthy subjects

ML Sargentini-Maier, P Espie, A Coquette… - Drug metabolism and …, 2008 - ASPET
This study was designed to investigate the human absorption, disposition, and mass balance
of 14 C-brivaracetam, a novel high affinity SV2A ligand with potent anticonvulsant activity. …

[HTML][HTML] First-in-human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti-CD40 monoclonal antibody

P Espié, YL He, P Koo, D Sickert, C Dupuy… - American Journal of …, 2020 - Elsevier
Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being
developed as an immunosuppressive agent. We describe a first-in-human, randomized, …

Gender and interindividual variability in pharmacokinetics

JM Nicolas, P Espie, M Molimard - Drug metabolism reviews, 2009 - Taylor & Francis
Like any other drugs, antiallergic medications can be associated with large inter- and
intraindividual variability in their disposition. The best-documented examples belong to the H1 …

[HTML][HTML] Characterization of the in vitro and in vivo properties of CFZ533, a blocking and non-depleting anti-CD40 monoclonal antibody

J Ristov, P Espie, P Ulrich, D Sickert, T Flandre… - American Journal of …, 2018 - Elsevier
The CD40-CD154 costimulatory pathway is essential for T cell–dependent immune responses,
development of humoral memory, and antigen presenting cell function. These immune …

A novel anti-CD40 monoclonal antibody, iscalimab, for control of Graves hyperthyroidism—a proof-of-concept trial

…, L Colin, A Amer, I Schuhmann, P Espie… - The Journal of …, 2020 - academic.oup.com
Context The CD40-CD154 co-stimulatory pathway plays an important role in the pathogenesis
of Graves disease (GD) by promoting autoreactive B-cell activation. Objective Evaluate …

Efficacy and safety of iscalimab, a novel anti-CD40 monoclonal antibody, in moderate-to-severe myasthenia gravis: A phase 2 randomized study

…, MN Meriggioli, A Genge, R Roubenoff, P Espié… - Journal of Clinical …, 2024 - Elsevier
Background Increased morbidity in many patients with myasthenia gravis (MG) on long-term
immunosuppression highlights the need for improved treatments. The aim of this study is to …

First‐in‐human study demonstrating the safety and clinical efficacy of novel anti‐IL‐17A monoclonal antibody CJM112 in moderate to severe plaque psoriasis

…, F Di Padova, C Calonder, P Espie… - Journal of the …, 2021 - Wiley Online Library
Background and objective Anti‐IL‐17A IgG/κ monoclonal antibody CJM112 binds both IL‐17A
and IL‐17AF. The purpose of this First‐in‐Human study was to assess CJM112 effects on …

Nonclinical safety assessment of CFZ533, a Fc-silent anti-CD40 antibody, in cynomolgus monkeys

P Ulrich, T Flandre, P Espie, D Sickert… - Toxicological …, 2018 - academic.oup.com
CFZ533 is a pathway blocking, nondepleting anti-CD40 antibody that is in clinical development
for inhibition of transplant organ rejection and therapy for autoimmune diseases. A 26-…