Date: 2017-11-01
Type of
information: Presentation of results at a congress
phase: 1a
Announcement: presentation of results the 59th ASH Annual Meeting
Company: Syntimmune (USA - MA)
Product: SYNT001
Action
mechanism: monoclonal antibody.
Disease: autoimmune diseases that are dependent upon IgG
Therapeutic
area: Autoimmune diseases
Country:
Trial
details:
- Syntimmune’s 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 (PK) and pharmacodynamics (PD).
Latest
news:
- • On November 1, 2017, Syntimmune announced that clinical data from the Phase 1a single ascending dose, double-blind, placebo-controlled trial of Syntimmune’s lead drug candidate, SYNT001, will be presented at the 59th ASH Annual Meeting. The trial results demonstrated SYNT001 as an intravenous formulation was well tolerated with a favorable safety profile in healthy volunteers. The study also showed that administration of SYNT001 resulted in rapid, dose-dependent, durable, and clinically significant reductions of IgG and circulating immune complexes (CICs). IgG and CICs are key measures of FcRn’s biologic functions in effectuating disease activity. Disabling these highlights SYNT001’s significant promise as a treatment for IgG-mediated autoimmune diseases.
Is
general: Yes
