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Equillium's Itolizumab Shows Encouraging Safety, Tolerability Profile In Systemic Lupus Erythematosus Study


Equillium Inc (NASDAQ: EQ) has reported topline data from the Type A group of the Phase 1b EQUALISE study evaluating itolizumab in patients with systemic lupus erythematosus (SLE).

Data from the study showed that itolizumab was safe and well-tolerated and demonstrated a dose-dependent reduction of cell-surface CD6 expression on effector T cells, a leading indicator of drug activity.

The most frequent adverse events were mild to moderate injection site reactions.

In the Type A SLE group, a total of 34 patients received at least one dose of subcutaneously delivered itolizumab in dosing cohorts 0.4 mg/kg through 2.4 mg/kg.

For the highest dosing cohort (3.2 mg/kg), a total of eight subjects received at least one subcutaneous dose of itolizumab. Of those, four patients discontinued in the highest dosing cohort after one dose, two due to non-serious adverse events, and two due to voluntary patient discontinuation.

Changes in pharmacodynamic markers were consistent with the pharmacokinetics and mechanism of action of itolizumab.

The company says that in terms of potency, the pharmacodynamic data from the cohort receiving 1.6 mg/kg subcutaneously in the EQUALISE study is comparable to the 1.6 mg/kg cohort in the intravenously administered EQUATE study in patients with acute graft-versus-host disease.

Complete data set from the Type A SLE patients will be presented at a future medical conference.

Interim data from the Type B Lupus Nephritis patients are expected to be announced before the end of the year.

Itolizumab is an anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive many immuno-inflammatory diseases.

Price Action: EQ shares are trading 5.9% higher at $7 in the premarket on the last check Wednesday.


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Posted-In: Systemic Lupus ErythematosusBiotech News Health Care FDA General

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