2 November 2017 - - US-based FcRn biology specialist Syntimmune, Inc. has released clinical data from the Phase 1a clinical trial of its lead drug candidate, Synt001, a first-in-class monoclonal antibody that blocks FcRn-IgG interactions and is being developed for the treatment of a broad variety of autoimmune diseases that are dependent upon IgG, the company said.
The trial results demonstrated that Synt001 as an intravenous formulation was well tolerated with a favorable safety profile in healthy volunteers, and that administration of Synt001 resulted in rapid, dose-dependent, durable, and clinically significant reductions of IgG and circulating immune complexes.
The Phase 1a single ascending dose, randomized, double-blind, placebo-controlled trial enrolled 31 healthy male subjects at a single site in the US. Subjects were randomized to receive one of five dose levels of Synt001 or placebo.
The study's primary outcome measures were safety and tolerability. Secondary measures included pharmacokinetics and pharmacodynamics.
Syntimmune is advancing novel therapies based on understanding of the biology of the neonatal Fc receptor. Based upon pre-clinical models, FcRn functions as a core part of a central common pathway that enables abnormal IgG responses, making it a well-validated target for the treatment of IgG-mediated autoimmune diseases.