Equillium: Interim enrollment achieved in Phase 3 EQUATOR study for aGVHD

Equillium, announced that it has surpassed the interim enrollment target for the Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease aGVHD . Equillium expects to deliver the results of the EQUATOR interim data review to Ono during the third quarter, which will then trigger Ono’s three-month option exercise period to acquire Equillium’s rights to itolizumab. “Our clinical development team has done an excellent job of recruiting and activating trial sites globally,” said Bruce Steel, chief executive officer at Equillium. “While the interim data will be blinded to Equillium and Ono, our independent data monitoring committee will conduct an unblinded analysis of the data and make a recommendation whether the study should proceed to conclusion based on pre-determined futility and efficacy stopping boundaries. Having now met the enrollment threshold for the interim review, we believe we are well on track to meet our guidance of delivering this final data milestone to Ono during the third quarter, setting the timeline for Ono’s option exercise decision to acquire itolizumab, which will expire three months following delivery of the results of the interim analysis.” If Ono exercises the option, Ono will pay Equillium a one-time payment of JPY 5.0 B or approximately $32.2M based on the currency exchange rate on May 8. Equillium is also eligible to receive up to $101.4M upon the achievement of certain development, regulatory, and commercialization milestones.