On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD).  GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality in patients receiving those transplants.  Currently, there is no approved therapeutic treatment for acute GVHD other than steroid treatment.  According to Equillium’s announcement, in the first two dose cohorts of the itolizumab study, called EQUATE, itolizumab was well tolerated.  In the first cohort, at a 0.4 mg/kg dose, two of four patients achieved a complete response by Day 29, and in the second cohort, at a 0.8 mg/kg dose, all three patients achieved a complete response by Day 15.  Based on these data, the independent data safety monitoring committee has recommended to proceed with a third cohort at a 1.6mg/kg dose.

Equillium also announced that it 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.  This request comes after July 2020 data from Equillium’s partner, Biocon Limited, which demonstrated that in a randomized, controlled, open label clinical trial conducted in India, itolizumab “significantly reduced mortality over one month as compared to placebo in patients hospitalized with COVID-19.”  Equillium announced that it will be working with Biocon in the further development and manufacturing scale-up of itolizumab for COVID-19 patients.