At the 2015 American College of Rheumatology Annual Meeting,
Olokizumab is a humanized monoclonal antibody that blocks IL-6, which is associated with a wide range of autoimmune and inflammatory diseases. It is an innovative anti-IL-6 agent selectively blocking receptor signaling of the IL-6 complex.
“The launch of the phase 3 program – CREDO (Clinical Rheumatoid Arthritis Development for Olokizumab) – for olokizumab is a major milestone for
CREDO program will consist of three pivotal phase 3 studies that were designed with input from key regulatory authorities (FDA/EMA) and will support regulatory submissions worldwide.
“We are building effective partnership with academia, leading research centers and are going to leverage several innovative approaches for this Phase 3 program” stated Mikhail Samsonov, Chief Medical Officer of
Mark Genovese, MD, Professor from Stanford University, a Principal Investigator for both the early phase studies and the CREDO program, stated “The launch of the CREDO program for Olokizumab is a positive step for RA patients. Many RA patients either do not respond, stop responding, or are intolerant to existing treatments, and by providing a new treatment option,
Prof. Genovese and colleagues presented an analysis of the long-term (48 week) data from the two Phase 2 studies completed with Olokizumab by UCB (ACR 2015, abstract 1649) in RA patients who have previously failed anti-TNF treatment.
The results of phase 2 clinical trials showed that reductions in disease activity were sustained to Week 48. Olokizumab demonstrated a safety profile consistent with the anti-IL-6 class of therapeutics.
The development of Olokizumab is supported by leading Russian academic institute for rheumatoid arthritis research – Nasonova Research Institute of Rheumatology. The first multinational multicenter randomized double-blind efficacy and safety phase 3 trial of Olokizumab will be initiated in the first half of 2016. The phase 3 program will be multinational with participating centers across Russia, EU, and North America.
About rheumatoid arthritis
Rheumatoid arthritis is a systemic connective tissue disease that primarily affects small joints. Due to chronic inflammation, this disorder causes pain and joint dysfunction; without appropriate treatment, it may lead to disability. The prevalence of rheumatoid arthritis is about 0.5-1.0% in the developed world. In Russia, there are approximately 1 million people with rheumatoid arthritis.