GSK announced the start of a phase II study to evaluate the efficacy and safety of GSK3196165, an investigational anti-granulocyte macrophage colony-stimulating factor monoclonal (anti GM-CSF) antibody, in patients with inflammatory hand osteoarthritis.
Osteoarthritis is a condition that causes damage to the surface of joints in the body leading to joint pain and stiffness. In some patients it can adversely affect work and normal daily activities.
The primary objective of the randomized, multicentre, double-blind, placebo-controlled parallel group study is to assess the efficacy potential of subcutaneous injections of GSK3196165 on pain. Secondary objectives include the assessment of safety and pharmacokinetics of GSK3196165.
GSK3196165 is one of the ~40 assets profiled to investors at GSK’s R&D event in November 2015 and belongs to the company’s immuno-inflammation portfolio – one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.
The asset is also in phase II development as a potential treatment for rheumatoid arthritis. It is not approved for use anywhere in the world.
Paul-Peter Tak, Chief Immunology Officer & Senior Vice President R&D Pipeline 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”.
Filed Under: Drug Discovery