Equillium Plans to Open Phase 1 Trial of EQ001 in Lupus Nephritis Patients Toward End of Year

Equillium announced that it is planning to test EQ001, its monoclonal antibody, in a Phase 1b trial as a potential therapy for patients with refractory lupus nephritis, among the most frequent and severe manifestations of lupus and one that can progress to kidney failure.

“Our decision to explore EQ001 for the treatment of lupus nephritis is consistent with our goal of developing promising new therapies that help patients with severe and underserved autoimmune diseases,” Daniel Bradbury, chairman and chief executive officer of Equillium, said in a press release.

Current standard of care therapies for lupus nephritis include corticosteroids (like oral prednisone) or immunosuppressants (like mycophenolate mofetil or cyclophosphamide). However, these therapies are linked with significant toxicities and rarely lead to long-term disease remission in people with lupus nephritis. Many patients are also refractory, or fail to respond, to them.

EQ001 is a monoclonal antibody that selectively targets CD6 preventing it from turning on important cellular pathways that control inflammation. Specifically, EQ001 blocks the binding of CD6 to ALCAM (activated leukocyte cell adhesion molecule), halting the activation of T-cells and their migration into tissues.

Previous research led by Chandra Mohan, MD, PhD, at the University of Houston, suggests that ALCAM is increased in patients with active lupus nephritis. The researchers won a $600,000 grant by the Lupus Research Alliance to study how ALCAM may participate in lupus nephritis, and if blocking its workings may improve a patient’s condition.

Overall these findings support the therapeutic potential of EQ001 for lupus nephritis, and suggest that measuring urinary ALCAM levels is a potential biomarker to identify patients more likely to respond to EQ001.

“[W]e believe EQ001’s unique mechanism of modulating both the activity and trafficking of pathogenic T cells provides a strong scientific rationale and highly differentiated approach to treat this difficult disease,” Bradbury added.

Equillium is planning to launch a Phase 1b proof-of-concept trial of EQ001 for lupus nephritis in the second half of this year. The study will assess the therapy’s safety and efficacy, as well as its pharmacokinetics profile (the movement of a medicine into, through, and out of the body).

The company will also collaborate with Chandra Mohan and the Lupus Research Alliance to further assess the predictive potential of the CD6-ALCAM pathway and other urinary proteins as biomarkers of disease progression and response to treatment.

“Targeting LN [lupus nephritis] is an important expansion of our pipeline that we are accelerating; given the central role that T cells play in LN immunopathogenesis, the CD6-ALCAM pathway represents an attractive and promising target in this indication for EQ001,” said Krishna Polu, MD, a nephrologist and chief medical officer of Equillium.

“By further leveraging and building upon the research conducted by Dr. Mohan, we believe that urinary biomarkers can be used as an efficient and pragmatic tool to study disease pathways and identify LN patients in which the CD6-ALCAM pathway may be a strong driver of the disease. … We look forward to initiating the LN clinical development program later this year,” Polu added.

“Using urinary biomarkers to guide therapeutic development aligns with our strategy of supporting work that will help accelerate delivery of new treatment,” said Kenneth M. Farber, Lupus Research Alliance president and chief executive officer.