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Equillium Announces Positive Interim Analysis from Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease
The Independent Data Monitoring Committee (IDMC) recommended continuation of the clinical trial based on safety assessment and pre-determined futility and
About this update from Equillium, Inc.
[{"type":"text","content":"\nThe Independent Data Monitoring Committee (IDMC) recommended continuation of the clinical trial based on safety assessment and pre-determined futility and efficacy stopping boundaries\n\n\nThe results of the IDMC review have been delivered to Ono Pharmaceutical Co., Ltd. triggering the 90-day period to exercise its option to acquire Equillium’s rights to itolizumab for JPY 5 billion plus potential milestone payments\n\n\n LA JOLLA, Calif.--(BUSINESS WIRE)--\nEquillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) based on its review of the interim results from the Phase 3 EQUATOR study evaluating itolizumab in subjects with acute graft-versus-host disease (aGVHD). The IDMC reviewed unblinded data on over 100 patients through Day 29 of treatment from the study, with pre-determined futility and efficacy stopping boundaries, and recommended that the study proceed with continued enrollment, without modifications.\n\n\n“We are pleased with the outcome of the interim review where the Independent Data Monitoring Committee did not raise any safety or futility concerns and recommended that the Phase 3 EQUATOR study continue as planned,” said Bruce Steel, chief executive officer at Equillium. “We have over 100 clinical sites worldwide enrolling patients and look forward to completing the study expeditiously. We believe that itolizumab may demonstrate a significant benefit for patients suffering from acute graft-versus-host disease, where mortality rates are very high and first-line standard of care remains high-dose corticosteroids. The blinded interim data along with the IDMC recommendation has been delivered to our partner, Ono Pharmaceutical, who has until the end of October 2024 to make its decision to acquire our rights to itolizumab, which would result in a one-time payment of JPY 5.0 billion, or approximately $35.0 million based on the currency exchange rate on August 5, 2024. Should Ono exercise its option, Equillium would also be eligible to receive up to USD $101.4 million upon the achievement of certain clinical, regulatory, and commercialization milestones.”\n\n\nAbout the EQUATOR Study\n\n\nThe Phase 3, randomized, double-...