Biotech Values

[DewDiligence]

The phase-2 trial you cited from Conatus Pharma has the oddest design of any HCV trial I’ve seen, notwithstanding the fact that it’s a second-line trial for first-line null responders.

No patients in the trial receive interferon, and the variable between the two trial arms is not the experimental drug, CTS-1027, as one might, but rather is ribavirin. I.e. one of the two trial arms is CTS-1027 monotherapy for 24 weeks!

That the FDA allowed this trial to be conducted shows an impressive (and somewhat surprising) willingness by the FDA to consider novel ideas in the second-line / null-responder setting. We previously saw an example of such thinking in the FDA’s granting permission for BMY to run an all-oral phase-2 trial in which neither individual drug had previously been tested in phase-2 (#msg-44700187).