Giaconda begins hep C trial

Sydney biotech Giaconda has started a Phase IIa clinical trial of its combination therapy Hepaconda for the treatment of hepatitis C.

The study is being carried out by the private Centre for Digestive Diseases in Sydney and the first patient has been enrolled and begun treatment.

According to Giaconda, the current standard treatment for chronic hepatitis C has limited efficacy, especially in genotype 1, and poor tolerability with the result that many patients cease treatment.

Genotype 1 hepatitis C virus has the lowest response rate to standard treatment compared to other genotypes and carries a higher risk of post-treatment relapses and progression to liver cirrhosis and liver cancer, the company said.

Hepaconda is a combination of bezafibrate and chenodeoxycholic acid, both of which have demonstrated activity against HCV as single compounds. Giaconda believes that the combination of bezafibrate with chenodeoxycholic acid may offer an advantage over current treatment.

The clinical trial is a two-centre, open label, prospective study of the efficacy and safety of the combination of chenodeoxycholic acid and bezafibrate in the treatment of subjects diagnosed with Hepatitis C Virus genotype 1, who have failed standard therapy (peg-interferon and Ribavirin combination therapy).

The purpose of the trial is to obtain a virological response and a reduction in viral load at three months and six months.

The secondary objectives are to obtain clinically significant improvements in elevated liver function tests at three and six months and to obtain an acceptable safety profile.

Subject to recruitment, it is anticipated that the trial will finish by the end of this year with results available in 2008.