Equillium receives fast track designation from FDA for EQ001
Equillium announced that the FDA has granted fast track designation for EQ001 for the treatment of acute graft-versus-host disease, or aGVHD. The company is planning to initiate a Phase 1b/2 clinical trial in early 2019, called the EQUATE trial, which will evaluate EQ001 for the treatment of patients presenting with aGVHD. The EQUATE trial is a Phase 1b/2 clinical trial that will enroll 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. The Phase 1b component is an open-label dose escalation trial and will be followed by the Phase 2 component, which is a randomized, double-blind, placebo-controlled trial in which subjects will receive either EQ001 or placebo in combination with corticosteroids over a two-month period.