Glenmark Pharmaceuticals has commenced a Phase IIb clinical trial of GBR 830 for the treatment of moderate-to-severe atopic dermatitis.
Under the double-blind, placebo-controlled trial, around 392 patients will be randomised across four dosing arms to receive GBR 830 and placebo.
The trial's primary objective is to compare the effectiveness of GBR 830 on reducing the severity of atopic dermatitis with placebo, as measured by Investigator’s Global Assessment (IGA).
Its secondary efficacy measures include patients with a greater than 75% improvement in disease severity, as measured by the Eczema Area and Severity Index (EASI). Other measures include disease activity using validated assessment tools such as EASI response and Scoring Atopic Dermatitis (SCORAD).
The trial will also assess safety, and biomarkers relevant to the disease and unique mechanism of GBR 830.
Patient enrolment for the trial is expected to begin in June this year.
Glenmark Pharmaceuticals president and chief medical officer Fred Grossman said: “The results of the Phase IIa trial completed last year demonstrated that GBR 830 was well-tolerated, and suggested signals of efficacy in the treatment of moderate-to-severe atopic dermatitis.”
GBR 830 is capable of inhibiting OX40, a co-stimulatory immune checkpoint receptor expressed on activated T-cells and memory T-cells.
Glenmark noted that co-stimulatory signals are vital for T-cell activity, and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases.
The activation of this pathway causes conversion of activated T-cells into memory T-cells, which promotes inflammation.
Glenmark is also exploring the potential of initiating trials of GBR 830 for the treatment of other inflammatory autoimmune conditions where dysregulation of OX40 overexpression is implicated in disease activity.