A potential monoclonal antibody GBR 830, developed by Glenmark Pharmaceuticals for treatment of moderate to severe atopic dermatitis (AD) successfully completed their Phase 2a clinical trial which shows promising results. The post hoc analysis data was presented at the American Academy of Dermatology (AAD) annual meeting in Washington DC.
AD is a chronic, inflammatory skin disease commonly associated with elevated levels of serum immunoglobulin E (IgE).
GBR 830 is an investigational anti-OX40 monoclonal antibody which is designed to inhibit OX40 which is a co-stimulatory receptor expressed on activated T cells. The binding between OX40 and OX40L is a biomarker for severity of autoimmune diseases. The activation of this pathway converts activated T cells into memory T cells promoting inflammation.
The study was conducted to evaluate the activity of GBR 830 in patients with intrinsic and extrinsic AD subtypes and subjects with elevated IgE levels. The analyses revealed a consistent effect in all these cases.
The study was performed in a small cohort of 62 randomized subjects of which 46 were treated with GBR 830 and the rest underwent a placebo conditioning. Of the 46 subjects 15 of them suffered from extrinsic AD and 27 had intrinsic sub-type of AD. After treatment with GBR 830 a decrease in SCORAD (scoring of atopic dermatitis) clinical scores was observed regardless of AD subtype or IgE level. The responses were observed shortly after first dose of GBR 830 and maintained through the study period and beyond.
“The consistent effect of GBR 830 observed across AD subtypes is important because not all AD therapies are effective or appropriate for all patients, thus increasing the need for precision in diagnosis and treatment,” said Mahboob Rahman, President and Chief Medical Officer at Glenmark Pharmaceuticals, in a press statement.
In the study, GBR 830 was safe and well-tolerated. The most common side-effect observed was headache, with no meaningful differences observed between GBR 830 (13%) and placebo-treated (25%) patients.
Glenmark Pharmaceuticals announced that a Phase 2b clinical trial of GBR 830 is underway and currently enrolling patients in the U.S. and Europe.