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Equillium Announces Positive Interim Data with Itolizumab in Acute GVHD Study
Complete response observed in five of seven patients in first two dose cohorts COVID-19 Pre-IND meeting request and briefing package submitted to the FDA LA
About this update from Equillium, Inc.
[{"type":"text","content":"Complete response observed in five of seven patients in first two dose cohorts\n COVID-19 Pre-IND meeting request and briefing package submitted to the FDA LA JOLLA, Calif., Aug. 10, 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 first two cohorts of the Phase 1b open label, dose escalation portion of the EQUATE study of itolizumab in acute graft-versus-host disease (aGVHD). Across the first two dose cohorts itolizumab has been generally well tolerated to date, and five of seven patients achieved a complete response (CR) by Day 29. Additionally, Equillium has submitted a request to the U.S. Food and Drug Administration (FDA) for a Pre-Investigational New Drug (Pre-IND) meeting to review its proposal to initiate a global randomized controlled clinical trial to study itolizumab in hospitalized patients with COVID-19. aGVHDThe EQUATE study is evaluating itolizumab in severe aGVHD patients – Grades III and IV – as a first-line treatment concomitant with standard of care, which is typically comprised of high dose corticosteroids, as no other therapeutics are currently approved for this indication. Across the first two dose cohorts of the Phase 1b open-label portion of the study 71% of patients achieved a CR by Day 29. In the first cohort at the 0.4 mg/kg dose, two of four patients achieved a CR, resulting in a CR and overall response (OR) rate of 50%. In the second cohort at the 0.8 mg/kg dose, all three patients achieved a CR, resulting in a CR and OR rate of 100%. Additionally, these CRs occurred early during itolizumab treatment course, with all patients achieving a CR within the first 15 days of treatment. Itolizumab has been well tolerated to date and adverse events have been consistent with those expected in this severely ill aGVHD patient population. Based on a thorough review of the available safety data across both cohorts, the independent data safety monitoring committee has recommended to proceed with dose escalation in the third cohort (1.6mg/kg) of the EQUATE study as planned. “We are very encouraged by the early response rates observed in the first two cohorts of aGVHD patients dosed with itolizumab, particularly since the individuals enrolled in the E...