The Food and Drug Administration (FDA) has granted Fast Track designation for itolizumab (EQ001; Equillium) for the treatment of lupus nephritis.

Itolizumab is a first-in-class monoclonal antibody that works by selectively blocking the immune checkpoint receptor CD6, which plays a central role in modulating T cells. The Company believes that itolizumab may also offer a wide range of therapeutic benefits for immuno-inflammatory diseases.

The phase 1b EQUALISE study is currently ongoing to evaluate the safety and tolerability of itolizumab in patients with systemic lupus erythematosus with or without active proliferative lupus nephritis. In addition, the Company is investigating itolizumab for the treatment of uncontrolled asthma and acute graft versus-host disease (aGVHD).

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“Receiving Fast Track designation recognizes the promising therapeutic potential of itolizumab for the treatment for lupus nephritis, particularly given its ability to modulate both the activity and trafficking of effector T cells,” said Krishna Polu, MD, chief medical officer. “Additionally, by monitoring levels of the CD6-ALCAM pathway in the urine in the EQUALISE trial we will be assessing the opportunity to take a personalized medicine approach to identify patients where the CD6-ALCAM pathway may be a dominant driver of the disease.”

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