- Vertex has completed planned enrollment of two of the three trials in Phase 3 registration program of VX-770, our potentiator compound
- We are on track to have pivotal data and submit an NDA for this compound in the second half of 2011
- We enrolled ahead of schedule the primary Phase 3 trial called STRIVE. This trial enrolled approximately 170 patients, age 12 and older with the G551D mutation.
- We have other completed planned enrollment, approximately 120 patients in the DISCOVER trial, which is primarily a safety study evaluating patients with the delta F 508 mutation.
- ENVISION trial which is enrolling younger patients with the G551D mutation, age 6 years to 11 years is ongoing and on track to complete enrollment in the first half of 2010.
- We expect that all patients in the STRIVE and DISCOVER trials will have received their first dose of 770 or placebo by the end of February.
- Patients in STRIVE are being dosed for 48 weeks with a primary efficacy and evaluating FEB1 [ph] for 24 weeks. At this time it is our expectation to conduct a study through 48 weeks, which puts us on a time line of submitting an NDA in the second half of 2011.
- So my personal assumption and belief is 770 has a broader use than just G551D patients. And the reason for that is because we have preclinical data that show potentiation is possible for a lot of different mutated channels. And so far preclinical data translated very nicely into the clinical performance.