Trial is going to recruit 400 patient this time with different dosage for treatment resistant partial epilepsy. Previous trials used 900 mg dose tid in small sample of 60 patients in phase II a. Study will be conducted for approximately 2 years or 25 months to see the reduction in seizure frequencies.
VX 765 is a caspase inhibitor which blocks IL-1b, thus decrease inflammation in the brain.
It would have been nice if they do a pilot study in post cardiac arrest patients to see if this drug, in addition to medically induced hypothermia, can decrease cerebral edema and thus anoxic brain injury. This is an unmet medical need that can bring bigger dollars than Hep C and CF.
VX 809 and VX 770 trial has 160 patients and if it is positive, VRTX may be able to file for NDA based on II b trial. This can be a good surprise to analysts.
Polymerase N5B target remains tricky and this probably will need 2 or more drugs to block the virus at this target site. I think non-nucleoside drugs will be safer than nucleoside inhibitors in long run and I am hoping to see a viable all oral result from Zenith trial.
Good luck and Happy new year to all longs. Drugs brings good business when they are most effective in their class.
These guidelines went into effect as a result of drugs designed to treat HIV. Basically, a parallel track is established in which drugs can be approved after P2 studies. Note that P3 studies still have to be run.