LusiNEX (tocilizumab; reference medical product Actemra®/ RoActemra®), a biosimilar acts as interleukin-6 receptor (IL-6R) antagonist. By binding IL-6R, it blocks the inflammatory response and alleviates joint erosion. The indication of Actemra®/ RoActemra® include Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA).
Rheumatoid arthritis (RA) is a chronic inflammatory disease that causes progressive joint destruction, and consequently functional disability due to combined effect of joint damage. Auto-immune attack leads to increased level of IL-6 and other inflammatory substances, and causes a series of inflammatory responses. Tocilizumab is a humanized monoclonal antibody against IL-6R, has demonstrated outstanding efficacy for the treatment of RA. As the patent of Tocilizumab will expire in 2019 in US, and Tocilizumab serves as one of the main therapeutics on non-TNFα antagonists for RA, Mycenax believes the development of LusiNEX will be a promising route together with TuNEX (TNF-α inhibitor) to build up a portfolio for RA.
Australian Government Department of Health has approved the phase I application (TGA, Therapeutic Goods Administration) for LusiNEX in September 2017. In addition to the approval from TGA, CTA will be submitted to Europe in the end of 2017. Mycenax is actively looking for licensing partner of phase III clinical trial who have capability of local trial management.