- The FDA approves FibroGen's (NASDAQ:FGEN) IND for the study of FG-3019 in Duchenne muscular dystrophy (DMD). The company intends to start a multi-site Phase 2 trial in non-ambulatory DMD patients later this year.
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FG-3019, one of the company's two lead product candidates, is a fully human monoclonal antibody that inhibits connective tissue growth factor (CTGF), a common mediator of fibrotic disease. CTGF is a protein found in the extracellular matrix that plays a key role in many biological processes including cell adhesion, migration, proliferation and angiogenesis. It is also being investigated for the treatment of ideopathic pulmonary fibrosis and pancreatic cancer.
- FibroGen will have to hustle despite its non-ambulatory focus. The list of companies working on DMD-targeted therapies is quite long: (NYSE:PFE) (NASDAQ:SRPT) (NASDAQ:RNA) (NASDAQ:PTCT) (NASDAQ:MRNA) (NASDAQ:CAPR) (OTCPK:SPHDF) (NASDAQ:BMRN) (NASDAQ:SMMT)