Biotechnology - South San Francisco, California, United States
Sr. Vice President Regulatory Affairs and Quality Assurance
Tobira is focused on developing and commercializing innovative therapeutics to treat liver disease, human immunodeficiency virus, or HIV-1, fibrosis and inflammation. Its lead product candidate, cenicriviroc, or CVC, is a proprietary immunomodulator that may be used to treat a number of diseases, including NASH, kidney fibrosis, HIV-1 and others. Tobira's management team has extensive experience in developing and commercializing therapeutics for liver disease and HIV-1.The lead indication for CVC is non-alcoholic steatohepatitis, or NASH, for which Tobira plans to begin a Phase 2 clinical trial in the second half of 2014. The company believes there are no other product candidates in development for NASH that target the immuno-inflammatory pathways responsible for fibrosis.CVC also is Phase 3-ready in HIV-1 infection with potential as the backbone in a fixed-dose combination therapy. CVC is a once-daily pill with a safety and tolerability profile that has been established to date in 550 subjects dosed in completed Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks.
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