GSK's Stiefel Begins Phase 3 Study For Ofatumumab

GlaxoSmithKline announced that its company Stiefel has begun the Phase 3 study of subcutaneous ofatumumab in rare autoimmune skin disorder, pemphigus vulgaris.

Ofatumumab is a human monoclonal antibody (mAb) designed to target an epitope in the CD20 molecule, including parts of the small and large extracellular loops. The drug is currently being developed by GSK and Genmab in collaboration.

The global, double-blind, randomized, multicenter, placebo controlled, parallel group Phase 3 study will investigate the tolerability, safety, and efficacy of subcutaneous ofatumumab in pemphigus vulgaris. The goal is to determine if the drug is capable of causing remission when the drug is used as adjunct to oral steroids versus placebo as an adjunct treatment. Secondary endpoints include antibody levels, B-cell depletion and repletion, immunogenicity, and other quality of life endpoints.

Pemphigus vulgaris is a rare and chronic skin disorder brought about by a malfunction in the immune system. The body produces antibodies that attack healthy cells and mucous membranes in the skin, leading to burn-like blisters in the mouth and on the skin. The disorder can lead to secondary skin infections, sepsis, dehydration, and death. Pemphigus vulgaris affects an estimated 7 people per million around the world. Patients being treated for this autoimmune skin disorder currently rely on chronic and high dose systemic steroids.

Dr. Kathy Rouan, SVP and Head of R&D, Stiefel, said, “The initiation of this study is an important step towards providing a potential new treatment option for patients suffering from this painful and potentially debilitating skin disease.”