Building a Multi-Indication Platform with Cenicriviroc
Our lead product candidate cenicriviroc (CVC) is under evaluation to treat a number of serious illnesses including non-alcoholic steatohepatitis (NASH) and HIV-1
CVC for NASH
NASH is a severe type of non-alcoholic fatty liver disease, or NAFLD, with no approved therapies. NASH affects 3 to 5 percent of the US population and can lead to life-threatening complications such as cirrhosis and liver cancer. Based on safety data from approximately 580 subjects who have received CVC in Phase 1 and 2 studies and statistically significant improvements in fibrosis in animal models, CVC is being evaluated in patients who have no approved therapies for this chronic disease. Tobira is currently enrolling patients in CENTAUR, a global randomized Phase 2 study of CVC vs placebo in patients with NASH and liver fibrosis.
CVC/3TC for HIV-1
Approximately 35 million people worldwide are living with HIV-1 infection and there is no cure. The mainstay of HIV-1 care is lifelong multi-drug therapy, which can be often accompanied toxicity associated with chronic use. CVC as part of a fixed-dose combination with lamivudine (3TC) has the potential to provide a new combination backbone to help address the unmet need for less toxic agents.
Tobira is advancing clinical development programs in NASH and HIV-1.
Tobira is also investigating CVC in other potential indications such as graft versus host disease and certain cancers where an immune-inflammatory cascade leads to either fibrosis or organ failure.
- 1.20.15 Tobira Therapeutics Doses First Subject in Phase 1 Clinical Trial of Cenicriviroc and Pioglitazone
- 1.14.15 Regado Biosciences and Tobira Therapeutics Announce Merger Agreement to Create Leading NASH Company
- 1.6.15 Tobira Therapeutics Cenicriviroc Granted Fast Track Designation by the FDA for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients with Liver Fibrosis