AVI Biopharma is reporting disappointing results from a Phase II trial of AVI-4065 for the treatment of hepatitis C. AVI-4065 did not meet the primary endpoint for efficacy, and the company says the therapeutic threshold necessary for drug efficacy was not achieved at the tested dosing level. AVI is adjusting the protocol and will test the drug at higher doses. AVI shareholders indicated their concern by sending shares of the drug developer down about 11 percent in early trading.
"Although it is always disappointing not to achieve clear clinical success on an initial trial targeting a new disease, it is encouraging that we observed a significant pharmacodynamic effect that we believe can be fine-tuned to provide a clinical benefit," said Denis R. Burger, Ph.D., AVI CEO in a press release. "We are fortunate that Neugene antisense technology provides flexibility for clinical protocol modification."
- read the AP report on the trial data