Mycenax Biotech Inc. announces TGA approval of phase I clinical trial authorization application for LusiNEX to treat autoimmune diseases

October 10, 2017 I Mycenax announced that the of Australian Government Department of Health and Ageing has approved the phase I application for LusiNEX, Mycenax’s biosimilar product of Actemra®/ RoActemra® being developed to treat autoimmune diseases. 

LusiNEX (tocilizumab; reference medical product Actemra®/ RoActemra®), is a biosimilar acting as interleukin-6 receptor (IL-6R) antagonist. By binding IL-6R, it blocks the inflammatory responses and alleviates joint erosion. LusiNEX is developed for treatment of immunology and musculoskeletal disorders, including Rheumatoid arthritis (RA), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). 

Worldwide, nearly 4.5 million adults are diagnosed with RA each year, and this trend is expected to grow due to aging population and advanced diagnosed technics. However, the high cost of biologics limits the access of treatment and causes economic burdens among health authorities. As a CMC-based biotech dedicated in process development of biologics, Mycenax reinforces its commitment to develop affordable, high quality products to patients with RA.

In addition to the approval from TGA, CTA submission in Europe is expected in October 2017. 190 healthy volunteers are planned to be enrolled for this clinical trial. Un-blinded data of LusiNEX is expected to be available in the second quarter of 2017; the primary endpoint of pharmacokinetics will be assessed and analyzed by then. Mycenax is actively looking for licensing partner of phase III clinical trial who have capability of local trial management. 

SOURCE: Mycenax Biotech

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