US biotech Equillium (Nasdaq: EQ) reported Thursday that its lead drug candidate itolizumab failed to meet the main objective in a Phase III trial for patients with acute graft-versus-host disease, sending shares tumbling in pre-market trading.
The EQUATOR study evaluated itolizumab as a first-line treatment in combination with corticosteroids, compared to placebo and steroids alone. Top-line data showed no significant difference in complete response rates at 29 days, the trial's primary endpoint. The overall response rate at 29 days, a key secondary measure, was also similar between the arms.
Despite this, Equillium said itolizumab delivered meaningful results in several longer-term outcomes. These included a higher complete response rate at day 99 and significant improvements in both duration of response and failure-free survival. The antibody was also well tolerated, with no added safety risks, including infection or sepsis.
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