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news.US-based biopharmaceutical firm Tobira Therapeutics has started dosing in a Phase I trial to evaluate the pharmacokinetics and safety in healthy patients of cenicriviroc (CVC) and the diabetes medication pioglitazone, both when administered alone and in combination.
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The trial supports the company’s larger clinical program of CVC in non-alcoholic steatohepatitis (NASH), a disease associated with multiple comorbidities, including diabetes.
The company said that pioglitazone is approved to improve glycemic control in patients with type 2 diabetes mellitus and has previously been examined in NASH.
Additionally, the company believes that the eventual approach to treating NASH will include multiple therapies to address the comorbidities of NASH, including type 2 diabetes.
The open label, fixed-sequence, three-period crossover trial will be conducted in two randomized groups of ten healthy subjects each.
Currently, cenicriviroc is being evaluated in the company’s randomized, double-blind Phase IIb CENTAUR trial carried out in around 250 patients with NASH and liver fibrosis, including patients with type 2 diabetes mellitus.
Tobira Therapeutics chairman and CEO Laurent Fischer said: "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.
"This study will allow us to further build CVC’s safety profile in combination with agents that are currently used in the NASH population."
The company also intends to conduct a trial, named ORION, to study the effects of CVC on peripheral and adipose tissue insulin sensitivity in obese subjects with prediabetes and suspected non-alcoholic fatty liver disease (NAFLD).