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Equillium announced that due to the rapidly evolving COVID-19 treatment landscape, the company will not initiate the EQUINOX Phase 3 clinical trial to evaluate itolizumab in hospitalized COVID-19 patients at this time. "Based on a thorough review of recent updates regarding the efficacy of new potential vaccines and other treatment options, we have made the strategic decision not to initiate our EQUINOX Phase 3 trial as previously planned. We are continuing to assess the rapidly evolving clinical and commercial landscape related to this pandemic and may consider other options to evaluate itolizumab in COVID-19 patients, including government research initiatives," said Bruce Steel, CEO of Equillium. "While this is a difficult decision given the current high rates of infection and significant unmet medical need, we believe it is prudent given the recent positive advancements by our biopharma colleagues to combat this serious pandemic. We greatly appreciate the support and effort of our trial investigators, clinical trial sites, and our Equillium team who played a vital role in preparing for the EQUINOX study, especially during this challenging time. Based on recent positive itolizumab interim clinical data in acute graft-versus-host disease we plan to prioritize our resources on expanding and accelerating this program, as well as advancing our lupus / lupus nephritis and uncontrolled asthma studies. We look forward to providing additional pipeline updates at our Analyst Day on Friday, December 4."

Equillium 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. 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 and one patient achieved a very good partial response by Day 29. 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 and proceed forward with enrollment. Equillium has received fast track designation from the FDA for the treatment of itolizumab in patients with aGVHD and orphan drug designations from the FDA for both the prevention and treatment of aGVHD. Equillium plans to provide additional updates on the program at its upcoming analyst day on December 4, 2020.