bad news

This would have to be considered very concerning data. As it currently stands, the expectation of new medications to treat HCV is that they cause little or no side effects to enable use across all demographics with high compliance rates. For there to be a significant difference in withdrawals from the BIT225 arm over placebo means that the findings in the earlier trials where there was suspicion of GI intolerance were probably real. They have rationalised this in the press release by suggesting that the BIT225 doses were too high, but there is great risk now that even dose reduction will not solve that problem. This has made BIT225 a lot less attractive to any company considering Biotron as a trial partner. In addition, the viral pharmacokinetics appear less impressive than in the earlier trials, which is odd and may reflect the withdrawals in the BIT225 arm. Overall, for HCV the hill to climb appears to have become an awful lot steeper, and possibly insurmountable.