CLEAN-1, to evaluate safety and antiviral activity of clemizole in treatment-naive patients infected with HCV genotypes 1 and 2

Eiger BioPharmaceuticals has initiated patient dosing in CLEAN-1 clinical trial in patients chronically infected with the hepatitis C virus (HCV).

The trial, undergoing in centers in Australia and New Zealand, will investigate the antiviral effect of clemizole monotherapy in the absence of interferon.

CLEAN-1 will evaluate the safety and antiviral activity of clemizole, a first generation antihistamine, in 28 days of oral therapy in treatment-naive patients infected with HCV genotypes 1 and 2.

The company claims that direct antiviral study represents an important first step in evaluating the therapeutic potential of inhibiting a new target in HCV - small molecule inhibition of the interaction between NS4B and HCV-RNA that is required for HCV replication.

David Cory, president and CEO of Eiger, said: “This proof of concept study is an important first step in our comprehensive development strategy for clemizole and newly discovered NS4B-RNA binding inhibitors for the treatment of HCV. Inhibiting the NS4B-RNA interaction represents an exciting new approach toward developing interferon-free, virus-specific agents to treat HCV.”

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