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Equillium Announces Favorable Data From Phase 1b EQUALISE Study in Systemic Lupus Erythematosus Patients
Itolizumab administered subcutaneously was safe and well tolerated in patients with systemic lupus erythematosus Dose-dependent changes in pharmacodynamic
About this update from Equillium, Inc.
[{"type":"text","content":"Itolizumab administered subcutaneously was safe and well tolerated in patients with systemic lupus erythematosus Dose-dependent changes in pharmacodynamic markers observed with subcutaneous dosing were consistent with intravenous dosing of itolizumab LA JOLLA, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced favorable topline data from the Type A group of the EQUALISE study in patients with systemic lupus erythematosus (SLE). In this study, itolizumab, a monoclonal antibody selectively targeting the CD6-ALCAM pathway, was safe and well tolerated. In addition, itolizumab demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action. “These initial data from the EQUALISE study demonstrate a favorable safety and tolerability profile for subcutaneous delivery of itolizumab in SLE patients, with the most frequent adverse events being mild to moderate injection site reactions,” said Dolca Thomas, M.D., chief medical officer at Equillium. “These data – the first itolizumab data reporting on subcutaneous delivery – support that subcutaneous administration of itolizumab can deliver systemic pharmacokinetic levels that are needed to evaluate itolizumab’s efficacy and safety in chronic autoimmune disorders that require long term outpatient therapy. We look forward to assessing outcomes with six months of subcutaneous itolizumab administration in the Type B EQUALISE study in lupus nephritis patients.” The EQUALISE study is a Phase 1b open-label multiple ascending-dose study of itolizumab in subjects with SLE, with or without active proliferative lupus nephritis (LN). The study is evaluating the safety and tolerability of subcutaneous delivery of itolizumab in two separate groups. The Type A group of SLE patients included five cohorts receiving 0.4, 0.8, 1.6, 2.4 or 3.2 mg/kg of itolizumab, with doses administered on days 1 and 15. The Type B group of LN patients will receive either 0.8, 1.6 or 3.2 mg/kg of itolizumab for a total of 13 doses delivered every two weeks. In the Type A SLE group, a total of 34 patients received at least one dose of subcutaneously delivered itolizumab ac...