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April 25, 2016

Cocrystal begins Phase I trial of CC-31244 in healthy and HCV-infected subjects

Cocrystal Pharma has begun a Phase Ia/Ib clinical trial of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI), to treat chronic hepatitis C virus (HCV) infection.

Cocrystal Pharma has begun a Phase Ia/Ib clinical trial of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI), to treat chronic hepatitis C virus (HCV) infection.

Hepatitis C is a viral infection of the liver and as per the World Health Organisation estimate, in 2013 the disease affected more than 150 million people worldwide.

Most patients develop chronic infections that can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer.

The Phase Ia/Ib clinical trial of CC-31244 is currently enrolling subjects and has already dosed the first subject with no serious adverse events reported.

"Based on the drug’s preclinical safety profile, drug resistance profile and low nanomolar in vitro potency, the goal is to determine the antiviral activity and safety of CC-31244 in humans."

The company noted that the multi-centre, double-blind, randomised, placebo-controlled single ascending oral dose and multiple oral dose trial is designed to evaluate CC-31244’s safety / tolerability, pharmacokinetics including food effect and antiviral activity in up to 88 subjects.

The trial will involve two groups, A and B. Group A covers single ascending doses, and multiple doses in healthy volunteers, while group B includes multiple doses in HCV infected individuals.

The dosing of Group B will be conducted after the safety and pharmacokinetic review of Group A.

Cocrystal Pharma chief medical officer Douglas Mayers said: "Based on the drug’s preclinical safety profile, drug resistance profile and low nanomolar in vitro potency, the goal is to determine the antiviral activity and safety of CC-31244 in humans."

The company expects to use CC-31244, which has been developed using its structure-based drug design technology, in an all oral, ultra-short HCV combination therapy.

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