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.
