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Friday, February 5, 2010

Updates on VX-770 from Vertex's Earnings Call

Here are a few updates from Vertex's Earnings Cal on 2/4/10

  • 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.


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