R-Pharm announces the initiation of a Global Phase 3 Clinical Trial Program for IL-6 inhibitor

December 7

At the 2015 American College of Rheumatology Annual Meeting, R-Pharm presented the long-term results from a Phase 2 study of patients with rheumatoid arthritis treated with Olokizumab and announced the initiation of the global phase 3 program for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who previously failed DMARD therapy. Olokizumab is an interleukin-6 (IL-6) inhibitor, which was obtained by R-Pharm under a worldwide exclusive license from the Belgian Biopharmaceutical Company UCB Pharma S.A. for development and commercialization; anti-IL-6 class therapeutics are becoming more widely used in clinical practice. Multinational multicenter clinical trials of Olokizumab will be conducted in Russia, Europe, USA, and Asia. 

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 R-Pharm,” stated Vasily Ignatiev, Chief Executive Officer of R-Pharm. “The R-Pharm leadership believe that this step forward cements our commitment to becoming a global pharmaceutical organization, not only in manufacturing and commercialization, but also in clinical development.”

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 R-Pharm

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, R-Pharm is helping to address this unmet need.” 

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.

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