SOUTH SAN FRANCISCO, CA, USA I October 1, 2014 I Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company developing cenicriviroc (CVC) in liver disease and HIV, announced today that it will present clinical data showing an improvement in fibrosis scores associated with CVC treatment at the American Association for the Study of Liver Diseases Annual Meeting. The data highlights an analysis of fibrosis scoring measures APRI and FIB-4 in patients from the completed Phase 2b study of CVC in treatment-naive HIV-1 patients. The study results will be presented at The Liver Meeting on Saturday, November 8th in Boston, MA during the “Fibrosis: Clinical and Translational” poster session, poster #455.
In the Phase 2b study, 16 to 18 percent of patients in the CVC treatment arms had elevated APRI or FIB-4 scores at baseline, indicating a greater risk of the presence of fibrosis. The percentage of patients with elevated scores in the CVC treatment arms was reduced at both the 24-week and 48-week time points to 6 to 9 percent, depending on score and time point.
“This data provides clinical evidence that CVC may reduce liver fibrosis and further substantiates CVC’s anti-fibrotic effect seen in animal models of liver and kidney disease,” commented Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. “While the importance of CCR2 and CCR5 in inflammation and fibrosis has been well characterized in the scientific literature, it is encouraging to see clinical data supporting Tobira’s approach with CVC, as it targets a different pathway from other drugs in development. We look forward to evaluating the full potential of CVC in patients with NASH and liver fibrosis in our Phase 2b CENTAUR study.”
The CENTAUR study is a randomized, double-blind, Phase 2b global study to evaluate CVC in patients with NASH and liver fibrosis. Tobira has initiated patient screening for the CENTAUR study and recently completed a Phase 1 study in subjects with hepatic impairment.
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, HIV, fibrosis and inflammation. The company’s lead product, cenicriviroc (CVC), is a first in class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) and HIV. CVC’s safety and tolerability profile has been evaluated in approximately 580 subjects who have been dosed in Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks. Tobira is initiating a Phase 2b clinical trial to study CVC in patients with NASH. Tobira also plans to advance CVC in a fixed-dose combination for HIV type 1 infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing. Learn more at www.tobiratherapeutics.com.
SOURCE: Tobira Therapeutics
Post Views: 92
SOUTH SAN FRANCISCO, CA, USA I October 1, 2014 I Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company developing cenicriviroc (CVC) in liver disease and HIV, announced today that it will present clinical data showing an improvement in fibrosis scores associated with CVC treatment at the American Association for the Study of Liver Diseases Annual Meeting. The data highlights an analysis of fibrosis scoring measures APRI and FIB-4 in patients from the completed Phase 2b study of CVC in treatment-naive HIV-1 patients. The study results will be presented at The Liver Meeting on Saturday, November 8th in Boston, MA during the “Fibrosis: Clinical and Translational” poster session, poster #455.
In the Phase 2b study, 16 to 18 percent of patients in the CVC treatment arms had elevated APRI or FIB-4 scores at baseline, indicating a greater risk of the presence of fibrosis. The percentage of patients with elevated scores in the CVC treatment arms was reduced at both the 24-week and 48-week time points to 6 to 9 percent, depending on score and time point.
“This data provides clinical evidence that CVC may reduce liver fibrosis and further substantiates CVC’s anti-fibrotic effect seen in animal models of liver and kidney disease,” commented Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. “While the importance of CCR2 and CCR5 in inflammation and fibrosis has been well characterized in the scientific literature, it is encouraging to see clinical data supporting Tobira’s approach with CVC, as it targets a different pathway from other drugs in development. We look forward to evaluating the full potential of CVC in patients with NASH and liver fibrosis in our Phase 2b CENTAUR study.”
The CENTAUR study is a randomized, double-blind, Phase 2b global study to evaluate CVC in patients with NASH and liver fibrosis. Tobira has initiated patient screening for the CENTAUR study and recently completed a Phase 1 study in subjects with hepatic impairment.
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, HIV, fibrosis and inflammation. The company’s lead product, cenicriviroc (CVC), is a first in class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) and HIV. CVC’s safety and tolerability profile has been evaluated in approximately 580 subjects who have been dosed in Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks. Tobira is initiating a Phase 2b clinical trial to study CVC in patients with NASH. Tobira also plans to advance CVC in a fixed-dose combination for HIV type 1 infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing. Learn more at www.tobiratherapeutics.com.
SOURCE: Tobira Therapeutics
Post Views: 92
