Cocrystal Pharma has received an approval from the US Food and Drug Administration (FDA) to begin a Phase IIa clinical trial evaluating CC-31244 for the treatment of patients infected with hepatitis C virus (HCV).
The approval was given in response to an Investigational New Drug (IND) application submitted by Cocrystal to FDA.
The proposed trial aims to analyse the safety, tolerability and preliminary efficacy of CC-31244 with approved HCV drugs.
Its endpoints include changes in HCV RNA viral load, adverse events and laboratory abnormalities.
The beginning of the trial is scheduled to take place in the second quarter of this year, with results expected in the last quarter of the year.
Cocrystal Pharma vice-chairman and interim CEO Gary Wilcox said: “Based on the positive results from our Phase Ia/Ib study, we believe that CC-31244 has the potential to change the treatment paradigm for patients living with HCV providing a shorter therapy with existing HCV combination therapies and a substantial and durable antiviral effect.”
In August last year, the company revealed positive results from the Phase Ia/Ib trial of CC-31244 for the treatment of chronic hepatitis C infection.
The randomised, placebo-controlled trial examined single and multiple ascending doses of CC-31244 for determining safety/tolerability, pharmacokinetics, and antiviral activity in healthy subjects and patients with HCV infection.
In the Phase Ia part of the trial 30 healthy volunteers received single doses of CC-31244, while 12 healthy volunteers received repeated doses of CC-31244 for seven days.
In Phase Ib, 15 patients with HCV genotype-1 infection were given CC-31244 for seven days, while 18 subjects received placebo.
CC-31244 is an investigational, oral, highly potent, broad-spectrum non-nucleoside inhibitor with high barrier to drug resistance designed and developed by Cocrystal Pharma.
It is active against all six HCV genotypes, with low level cytotoxicity in several cell types.