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).

“The results of the Phase IIa trial completed last year suggested signals of efficacy in the treatment of moderate-to-severe atopic dermatitis.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.