Equillium is hoping that unmet medical need and long-term efficacy will persuade the US Food and Drug Administration to approve itolizumab for acute graft-versus-host disease (aGVHD) despite its Phase III trial failing to meet its primary endpoint and a key secondary endpoint.
Key Takeaways
- Equillium said the Phase III EQUATOR trial missed the primary and a key secondary endpoint in first-line treatment of acute GVHD while showing longer-term efficacy.
The La Jolla, CA-based biotech said 27 March that the Phase III EQUATOR study comparing itolizumab against placebo did not show statistical significance on the primary endpoint of complete response...