Debio 025 boosts Peg-IFN efficacy in Ph IIa study

Lausanne, Switzerland-based drug developer Debiopharm presented positive efficacy results from a Phase IIa study with Debio 025, a selective cyclophilin inhibitor. According to the firm, data indicates that Debio 025 shows an important additive anti-hepatitis C virus effect when co-administered with pegylated interferon (Peg-IFN) alpha-2a to treatment-naive HCV patients. Findings from the double-blind, placebo-controlled study were presented at the annual meeting of the European Association for the Study of the Liver, in Milan, Italy.

In patients with genotypes 1 and 4, at day 29, HCV-RNA reduction was -4.6 log10 IU/mL in the Peg-IFN with Debio 025 600mg/day arm, and -4.8 log10 IU/mL in the Debio 025 1,000mg/day arm. This was significantly different (p< 0.05) from Peg-IFN with placebo, as well as the Debio 025 1,000mg/day monotherapy arms, in which the reduction in viral load was respectively -2.49 and -2.20. In these two arms, at day 29, the proportion of subjects with undetectable viral load was 25%. This number increased to 66% in the Peg-IFN with Debio 025 1,000mg/day group.

"To obtain these exciting results after an administration period of only one month is promising and demonstrates that Debio 025 will be a breakthrough in the treatment of HCV infections," said company chief executive Kamel Besseghir. "This unique mechanism of action is the first alternative treatment to classic HCV therapies," he added.