GlaxoSmithKline (GSK) has started a Phase II study to assess the efficacy and safety of GSK3196165, a new anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody to treat patients with inflammatory hand osteoarthritis.
Osteoarthritis is a type of disease that causes damage to the surface of joints in the body leading to joint pain and stiffness, while it can adversely affect work and normal daily activities in some patients.
The multi-centre double-blind, randomised, placebo-controlled parallel group Phase II trial will investigate the efficacy and safety of subcutaneous injections of GSK3196165 in 40 adult subjects with inflammatory hand osteoarthritis.
Main objective of trial is to evaluate the efficacy potential of subcutaneous injections of GSK3196165 on pain, whilesecondary objectives cover the assessment of safety and pharmacokinetics of GSK3196165.
GSK3196165 is one of the 40 assets profiled to investors at GSK's R&D event held last November and belongs to the company's immuno-inflammation portfolio, which is one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.
The anti GM-CSF antibody is also in Phase II development as a potential treatment for rheumatoid arthritis. However, it is not approved for use anywhere in the world.
GSK R&D pipeline chief immunology officer and senior vice-president Paul-Peter Tak said: "We are pleased to be progressing GSK3196165, an anti GM-CSF antibody, which is part of our broad portfolio of innovative immuno-modulating medicines in clinic development, for another indication.
"The start of this study is our first step to help patients with osteoarthritis, a painful disease that can affect any joint in the body.
"We have begun our clinical plans by investigating the potential of GSK3196165 in a particular group of patients with hand osteoarthritis. We hope this study will provide informative results to shape our future plans for osteoarthritis."
Image source: Osteoarthritis is a type of disease that causes damage to the surface of joints in the body leading to joint pain and stiffness. Photo: courtesy of Drahreg01.