SOUTH SAN FRANCISCO, CA, USA I January 20, 2015 I Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today that it has dosed the first subject in a Phase 1 study to evaluate the pharmacokinetics and safety in healthy subjects of cenicriviroc (CVC) and the diabetes medication pioglitazone, both when administered alone and in combination. The study supports Tobira’s larger clinical program of CVC in non-alcoholic steatohepatitis (NASH), a disease associated with multiple comorbidities, including diabetes.
Pioglitazone is approved to improve glycemic control in patients with Type 2 diabetes mellitus and has previously been studied in NASH. In addition, Tobira believes that the eventual approach to treating NASH will include multiple therapies to address the comorbidities of NASH, including Type 2 diabetes.
The study is designed as an open label, fixed-sequence, three-period crossover study in two randomized groups of 10 healthy subjects each. For additional information on the study, visit www.clinicaltrials.gov, and use the identifier NCT02342067.
CVC is currently being evaluated in Tobira’s Phase 2b CENTAUR study (identifier NCT02217475). CENTAUR is a randomized, double-blind study designed to compare CVC to placebo in approximately 250 patients with NASH and liver fibrosis, including patients with Type 2 diabetes mellitus.
“Type 2 diabetes mellitus is a disease commonly associated with non-alcoholic steatohepatitis or NASH and NASH patients with Type 2 diabetes are often at greater risk of progression to advanced liver disease,” said Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. “This study will allow us to further build CVC’s safety profile in combination with agents that are currently used in the NASH population.”
Tobira also plans to conduct a study, named ORION (identifier NCT02330549), to examine the effects of CVC on peripheral and adipose tissue insulin sensitivity in obese subjects with prediabetes and suspected non-alcoholic fatty liver disease (NAFLD).
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV-1. 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 non-alcoholic steatohepatitis (NASH) and HIV-1. Tobira is actively enrolling patients in a Phase 2b clinical trial called CENTAUR to evaluate CVC in patients with NASH and liver fibrosis. On January 14, 2015, Tobira and Regado Biosciences (NASDAQ: RGDO) entered into a merger agreement that is expected to close in the second quarter of 2015. Learn more about Tobira at www.tobiratherapeutics.com.
SOURCE: Tobira Therapeutics
Post Views: 83
SOUTH SAN FRANCISCO, CA, USA I January 20, 2015 I Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today that it has dosed the first subject in a Phase 1 study to evaluate the pharmacokinetics and safety in healthy subjects of cenicriviroc (CVC) and the diabetes medication pioglitazone, both when administered alone and in combination. The study supports Tobira’s larger clinical program of CVC in non-alcoholic steatohepatitis (NASH), a disease associated with multiple comorbidities, including diabetes.
Pioglitazone is approved to improve glycemic control in patients with Type 2 diabetes mellitus and has previously been studied in NASH. In addition, Tobira believes that the eventual approach to treating NASH will include multiple therapies to address the comorbidities of NASH, including Type 2 diabetes.
The study is designed as an open label, fixed-sequence, three-period crossover study in two randomized groups of 10 healthy subjects each. For additional information on the study, visit www.clinicaltrials.gov, and use the identifier NCT02342067.
CVC is currently being evaluated in Tobira’s Phase 2b CENTAUR study (identifier NCT02217475). CENTAUR is a randomized, double-blind study designed to compare CVC to placebo in approximately 250 patients with NASH and liver fibrosis, including patients with Type 2 diabetes mellitus.
“Type 2 diabetes mellitus is a disease commonly associated with non-alcoholic steatohepatitis or NASH and NASH patients with Type 2 diabetes are often at greater risk of progression to advanced liver disease,” said Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. “This study will allow us to further build CVC’s safety profile in combination with agents that are currently used in the NASH population.”
Tobira also plans to conduct a study, named ORION (identifier NCT02330549), to examine the effects of CVC on peripheral and adipose tissue insulin sensitivity in obese subjects with prediabetes and suspected non-alcoholic fatty liver disease (NAFLD).
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV-1. 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 non-alcoholic steatohepatitis (NASH) and HIV-1. Tobira is actively enrolling patients in a Phase 2b clinical trial called CENTAUR to evaluate CVC in patients with NASH and liver fibrosis. On January 14, 2015, Tobira and Regado Biosciences (NASDAQ: RGDO) entered into a merger agreement that is expected to close in the second quarter of 2015. Learn more about Tobira at www.tobiratherapeutics.com.
SOURCE: Tobira Therapeutics
Post Views: 83
