Biotech Values

[DewDiligence]

The VX-222+Telaprevir phase-2 trial is notable in several ways:

• There is no SoC control arm. (Although not having an SoC arm is novel, it can’t be called surprising because it’s what I predicted in #msg-46326087.)

• Patients are required to have undetectable virus as early as two weeks from the start of treatment in order to discontinue treatment after 12 weeks. To my knowledge, no HCV trial has ever had such a stringent timing requirement for stopping therapy.

• The threshold for undetectability is <10 IU/ml, which reflects the sensitivity of the latest assays and reduces the likelihood of seeing cases of faux viral rebound.

• All arms in the trial use BID rather than TID Telaprevir, based on the positive outcome of JNJ’s C208 study (#msg-43114192).