Equillium Announces Interim Enrollment Achieved in Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today 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 billion, or approximately $32.2 million based on the currency exchange rate on May 8, 2024. Equillium is also eligible to receive up to $101.4 million upon the achievement of certain development, regulatory, and commercialization milestones.

About the EQUATOR Study

The Phase 3, randomized, double-blind, placebo-controlled multicenter study (NCT05263999) will compare the efficacy and safety of IV administered itolizumab versus placebo (randomized 1:1) as a first-line therapy in approximately 200 adult and adolescent patients with Grade III-IV aGVHD, or Grade II aGVHD with lower GI involvement, in combination with high doses of corticosteroids, the current standard of care. The primary study endpoint is complete response rate at Day 29; key secondary endpoints include overall response rate at Day 29 and durability of complete response rate from Day 29 through Day 99.