FDA Declines Breakthrough Therapy Status For Equillium's Itolizumab

(RTTNews) - Equillium, Inc. (EQ), a clinical-stage biotechnology company, Thursday said that the U.S. Food and Drug Administration (FDA) declined to grant Breakthrough Therapy designation for itolizumab for the treatment of acute graft-versus-host disease (aGVHD) based on the EQUATOR study data.

aGVHD is a serious complication that can occur after a stem cell or bone marrow transplant.

The FDA highlighted its attention to achieving response outcomes at Day 29, per existing FDA guidance, while itolizumab did not demonstrate improvements by Day 29. However, the regulator showed openness to evaluating other endpoints, including longer term outcomes, provided independent data supports the validity of such endpoints.

"Based on this feedback we plan to accelerate closure of the EQUATOR study," said Bruce Steel, chief executive officer at Equillium.