We all have been deeply impacted by the COVID-19 pandemic, both in ways predictable, such as maintaining physical distancing, and also in ways we never would have imagined. During these uncertain times, it is our industry’s privilege, responsibility and obligation to undertake safe and measured steps to produce therapeutic options for patients worldwide who are suffering from COVID-19.

At Equillium, while we remain focused on our core development programs with itolizumab, we also recognize the urgency of the need to develop drugs to treat COVID-19. We believe itolizumab’s novel immune-modulating mechanism, combined with data from prior human clinical trials – including recent positive interim data from our Phase 1b clinical study in acute graft-versus-host disease and Phase 2 study data in COVID-19 patients reported by our partner Biocon Limited – support our hypothesis that itolizumab may have promise in addressing immuno-inflammatory complications experienced by patients with COVID-19.

We recently shared that we received positive feedback from our pre-IND meeting with the FDA where we proposed advancing itolizumab into a potential Phase 3 registration study as a treatment for patients suffering from life-threatening consequences as a result of COVID-19 later this year.  This guidance from the FDA provides a well-defined regulatory pathway and we aim to work expeditiously to develop itolizumab to treat patients in the U.S. and abroad in the face of this global crisis.

We will continue to provide updates on matters regarding COVID-19 that may impact our development strategy with itolizumab, and hope that our peers in the biotechnology sector are successful in their efforts to combat this serious pandemic.

In the meantime, from the Equillium family to yours, we wish you good health and wellbeing during these unprecedented times.

Our best regards,

Bruce Steel, Chief Executive Officer