Quantitative Modeling in Support of the Development of a Systemic Lupus
Erythematosus Drug
Konstantinos (Kostas) Biliouris, PhD
Principal Pharmacometrics Scientist, Novartis, Cambridge, MA, USA
Wednesday, Dec 13, 2017, 12:00 pm to 1:00 pm EST
Register at https://register.gotowebinar.com/register/1722787768122350082
Abstract: Systemic lupus erythematosus (SLE) is a rare, chronic auto-immune
disease. Type I interferons, that are primarily produced in plasmacytoid
dentritic cells, play a major role in the pathogenesis of SLE as well as its
cutaneous form CLE.
BIIB059 is a humanized Fc effector function-competent immunoglobulin G1
monoclonal antibody (mAb) under development for the treatment of SLE and CLE.
It specifically binds BDCA2, a receptor uniquely expressed on the surface of
human and non-primate pDCs. BDCA2 receptor engagement by BIIB059 has been shown
to mediate inhibition of IFNα/β expression, which is expected not only to treat
the active disease (e.g. lupus skin lesions) but also to inhibit disease
progression in SLE.
In this presentation, I will be discussing the development of a population
PK/PD model for BIIB059. This model will be utilized in selecting the doses for
upcoming Phase 2 studies.