Equillium's Single Phase 3 Study In aGVHD To Support US Filing Of Itolizumab

Equillium Inc EQ completed an End-of-Phase 1 meeting with the FDA, confirming to advance itolizumab into a single Phase 3 pivotal study in first-line treatment of acute graft-versus-host disease (aGVHD) patients.
The company plans to initiate the Phase 3 study in 4Q of 2021.
The FDA meeting guided on the pivotal study design and advice on chemistry, manufacturing, and controls, nonclinical and regulatory-related.
The randomized double-blinded pivotal study will evaluate one dosing regimen of itolizumab versus standard of care (high-dose corticosteroids). It will include a complete response at Day 29 as the primary endpoint, with an interim evaluation for futility and efficacy at 50% patient enrollment.
Price Action: EQ shares are up 6.7% at $6.02 during the premarket session on the last check Tuesday.
Related content: Benzinga's Full FDA Calendar.