The final data from the Ph 2 study of VX-890 and Kalydeco were provided on June 28. What additional information is likely to be provided in Poster #260 (the abstract is attached below) next Thursday?
“The Investigational CFTR Corrector, VX-809 (Lumacaftor) Co-Administered with the Oral Potentiator Ivacaftor Improved CFTR and Lung Function in F508DEL Homozygous Patients: Phase II Study Results.” Poster #260. An oral presentation is scheduled for October 11, 2012, 11:40 a.m. EDT.
The data reported on June 28 do not provide the time course (except the beginnings and endings of dosing of the two drugs) and VX-809 dose dependence of the time courses for the development of FEV1 and sweat chloride. An oral presentation often accompany a set of chart or table slides which display such time development and the dose response. This should include the time course of the placebo. These data presentations are critically important. The reason is that the signals are weak and noise is not negligible because the Ph 2 trial was small in participant number and short in dosing duration. I hope that they present a good set of market convincing plots.
In the today's blog by AF, he stated that the Ph 3 trial may include 400 mg bid dosing of Kalydeco. That is an error. It is VX-809 that will be dosed at 400 mg twice daily.