Posted by Michael Wonder on 19 Dec 2018
Equillium granted U.S. FDA fast track designation for EQ001 for the treatment of acute graft-versus-host disease
19 December 2018 - Company plans to initiate Phase 1b/2 EQUATE clinical trial in early 2019.
Equillium today announced that the U.S. FDA has granted fast track designation for EQ001 for the treatment of acute graft-versus-host disease (aGVHD).
The EQUATE trial is a Phase 1b/2 clinical trial that will enrol approximately 84 patients to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of EQ001 for the initial treatment of aGVHD in combination with corticosteroids (NCT 03763318). The Phase 1b component is an open-label dose escalation trial and will be followed by the Phase 2 component, which is a randomised, double-blind, placebo-controlled trial in which subjects will receive either EQ001 or placebo in combination with corticosteroids over a two-month period.
