Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease

100% overall response rate in dose cohort 3 and 80% overall response rate across all cohorts to date
Complete response observed in seven of eight responding patientsEQUATE Phase 1b topline data expected during first half 2021LA JOLLA, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) — Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced positive interim data from the third cohort of the Phase 1b open label, dose escalation study of itolizumab in the first-line treatment of acute graft-versus-host disease (aGVHD). The EQUATE trial is evaluating itolizumab in severe aGVHD patients concomitant with standard of care, which is typically comprised of high dose corticosteroids, as no other therapeutics are currently approved for this indication. Equillium anticipates reporting topline data across all cohorts from the Phase 1b portion of the EQUATE trial during the first half of 2021 and is accelerating plans for further development of itolizumab in graft-versus-host disease.In the EQUATE trial, the overall response rate across the first three dose cohorts was 80%, and seven of eight patients responding achieved a complete response (CR) and one patient achieved a very good partial response (VGPR) by Day 29 (VGPR approximates the clinical benefit of CR). Responses observed have been rapid, with most patients achieving a CR within the first 15 days, and durable as patients in the first two cohorts have maintained responses through Day 57. To date, adverse events reported with the EQUATE trial have been consistent with the safety profile previously reported for itolizumab and those common in the aGVHD patient population. In review of the totality of safety, efficacy and pharmacodynamic data, the independent data monitoring committee has recommended to expand cohort 3 (1.6 mg/kg dose) and proceed forward with enrollment.“We continue to accrue compelling data in the EQUATE trial – the rapid and durable response rates in patients treated with itolizumab meaningfully exceeds what has been observed in patients with severe aGVHD treated with steroids alone,” said Bruce Steel, chief executive officer of Equillium. “We plan to engage the U.S. Food and Drug Administration (FDA) to explore expedited regulatory pathways to advance itolizumab for the first-line treatment of aGVHD. Further, this data suggests opportunities to expand the potential therapeutic application of itolizumab for patients with chronic GVHD and as a potential preventative treatment for patients who have undergone hematopoietic stem cell transplantation. We believe itolizumab has the potential to be a life-saving medicine for aGVHD patients, a severe and life-threatening illness for which there are currently no approved therapeutics.”