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news.US-based biopharmaceutical firm Tobira Therapeutics has secured Fast Track designation from the US Food and Drug Administration (FDA) for cenicriviroc (CVC) to treat nonalcoholic steatohepatitis (NASH) in patients with liver fibrosis.
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Currently, the company is enrolling patients in its randomized, double-blind Phase IIb proof of concept trial designed to compare CVC to placebo in around 250 patients with NASH and liver fibrosis.
Tobira Therapeutics chairman and CEO Laurent Fischer said: "The designation of Fast Track for CVC and our CENTAUR clinical program are aligned with recommendations from the joint FDA and American Association for the Study of Liver Disease workshop that identified potentially acceptable surrogate endpoints for clinical studies of agents for NASH and liver fibrosis, a disease for which no treatments are approved.
"We look forward to continuing our collaboration with the FDA on the development of CVC in patients with NASH and liver fibrosis in the CENTAUR study."
CVC is a first in class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated to treat NASH and HIV.
The product’s safety and tolerability profile has been evaluated in around 580 subjects who have been dosed in Phase I and Phase II trials, including a safety study in subjects with liver cirrhosis and 115 HIV-1 infected subjects on treatment for up to 48 weeks.