The second phase of this exploratory trial was designed to assess the safety, tolerability, pharmacokinetics, and response to treatment with AVI’s proprietary compound, AVI-4065, developed from the company’s NeuGene technology.
AVI said that the therapeutic threshold required for efficacy of the drug was not achieved at the treatment dose used, which was consistent with preliminary results.
The company added that there was a direct pharmacodynamic response to hepatitis C infection. AVI-4065 also exhibited favorable safety and tolerability profiles.
“It is encouraging that we observed a significant pharmacodynamic effect that we believe can be fine-tuned to provide a clinical benefit,” said Denis Burger, AVI CEO.
AVI has said they will continue to research NeuGene technology and are planning to increase treatment duration and dosage in order to exceed the therapeutic threshold predicted from preclinical models.
Hepatitis C is a single-stranded RNA virus. Because the hepatitis C virus has a relatively simple genetic structure, it is an attractive target for AVI’s NeuGene antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time.