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Last results of the phase 3 cinical trial VX661 and ivacaftor
- Question
- Hello
could you inform us regarding results of the clinical phase 3 which has just ended with patients homozygous for the F508del mutation and performed by the Vertex company.
Thank you
- Answer
- Hello
A clinical phase 3 for the evaluation of the efficacy of Ivacaftor (VX770) associated with Lumacaftor (VX809) has just ended and the first results published.
Around 1000 patients up to 12 years, homozygous for the F508del mutation have participated: during 24 weeks patients received Ivacaftor (250 mg, twice a day) and Lumacaftor (600 mg or 400 mg, twice a day) or placebo.
The results available today show a statistically significant improvement in lung function (FEV1) for patients who received the combination regimens compared to those who received placebo. At the end of the study, a mean absolute improvement in FEV1, compared to placebo, with a range of 2.6 to 4.0 percentage points has been observed in patients under treatment. Other benefices have been observed as weight gain, decrease of number of exacerbations.
No clinical phase 3 has been performed with VX661 associated to Ivacaftor.
Best regards,
Anna Ronayette
- 29.07.2014
