Potential steroid-sparing treatment enters SLE, IgG4-RD phase 2 trials

Xencor Inc. announced dosing of the first patient in a phase 2 trial of XmAb5871 to potentially treat patients with systemic lupus erythematosus, according to a company press release.

In addition to patients with systemic lupus erythematosus (SLE), the first dose of the same drug also has been administered in a trial of patients with immunoglobulin G4-related disease (IgG4-RD). The IgG4-RD trial is a single-arm, open-label study at Massachusetts General Hospital, while the SLE trial is a randomized, double-blind placebo-controlled, multiple dose trial in the United States at about 20 locations with about 90 patients with SLE. Following a short course of intramuscular steroids, patients with SLE without organ involvement will discontinue background immunosuppressive medication. Patients will be randomized 1:1 with either XmAB5871 or placebo received as infusions every 2 weeks, for up to 12 infusions. Lack of disease progression is the target outcome.

“We are advancing XmAb5871 in IgG4-RD and SLE because of its potent, reversible B-cell inhibition and promising treatment effect demonstrated in a phase 1b/2a study of patients with rheumatoid arthritis, as well as previous ex vivo results with XmAb5871 showing inhibition of SLE patient B-cell activation and humoral immunity,” Bassil Dahiyat, PhD, president and chief executive officer of Xencor, said in the release. “B-cell inhibition by XmAb5871 has potential in a number of autoimmune diseases, and we believe we can execute efficient clinical trials with clear outcomes in these indications and potentially address high unmet needs. In IgG4-RD, a newly defined disease, we have the opportunity to be at the forefront of providing a treatment for patients.”

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