Biotech Values

[DewDiligence]

Have there been any safety signals to date with respect to the BI compound [BI 201335]? After taking a quick review of your links under the "Most Likely To Succeed" table, it looks like the side effects to date have been mostly attributable to peg-interferon.

From the BI 201335 presentation at 2009 AASLD* (#msg-42086185):

There were no SAE in the 240mg QD group and 2 SAE in the 240mg BID group. Both were cases of mild to moderate hepatic decompensation attributed to PegIFN/RBV by the investigators.

Two patients in the BID group discontinued treatment early, one due to nausea, one due to hepatic decompensation (SAE). Jaundice due to isolated unconjugated hyperbilirubinemia was reported in 2/6 and 1/7 patients at 240mg QD and BID, respectively. Other AE were mainly mild to moderate and typical of PegIFN/RBV. Lab analyses showed decreases of ALT / AST as well as blood cell counts typical of PegIFN/RBV.

I tend to be suspicious of cases like this one where all of the SAE’s are blamed on the “other” drugs. I think the jury is still out on the safety profile of BI 201335.

*Also see the paper presented at AASLD in 2008: http://www.natap.org/2008/AASLD/AASLD_13.htm .