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Equillium Announces Positive Topline Results from the EQUATE Study in First-line Treatment of Acute Graft-Versus-Host Disease
Itolizumab continues to demonstrate favorable safety and efficacy profile Rapid and durable responses resulted in clinically meaningful reduction in
About this update from Equillium, Inc.
[{"type":"text","content":"Itolizumab continues to demonstrate favorable safety and efficacy profile Rapid and durable responses resulted in clinically meaningful reduction in corticosteroid use Data support clinical advancement of itolizumab in first-line treatment of aGVHD Conference call today at 8:00 am eastern time LA JOLLA, Calif., June 11, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Phase 1b EQUATE study in first-line 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. There are no approved treatments for this severe, life threatening disease. The results were presented this morning in an oral presentation at the European Hematology Association 2021 Virtual Congress by John Koreth, M.D., associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School. All patients in the study (N=20) were evaluated as high-risk (grades 3 and 4) aGVHD and achieved complete response (CR) and overall response rates (ORR) at Day 29 of 55% and 70% respectively. Responses observed were generally rapid – within 15 days – and durable through Day 29 and beyond. Six patients received therapy between four and nine days after steroid administration and were generally characterized as steroid refractory. Fourteen patients were characterized as treatment naïve – receiving itolizumab within three days of first steroid administration – and achieved CR and ORR of 64% and 71% respectively. Additionally, responding patients experienced clinically meaningful reductions in steroid administration. Across all dosing cohorts, 60% of patients (12/20) reported serious adverse events with only 10% (2/20) of these events reported as treatment related. There were 4 (20%) adverse events that led to death, and none were treatment related. Overall survival at month six across all dosing cohorts was 67%. Adverse events reported are consistent with a hospitalized, high-risk aGVHD patient population. “Topline results from the EQUATE study highlight that itolizumab continues to demonstrate promising safety and efficacy data in first-line treatment of acute graf...