2016 Earnings Summary
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Okay. So the first one, the 2222 study and indeed the study in CF patients, thank you for the question-- is a study on top of Kalydeco. So, we expect a couple of things from that study. Safety first, exposure of women [ph] patients, first with 2222. So we have quite of flexibility with 2222. And our hope for that is that the PK will be as expected. But that's the first thing that we expect there. Safety exposure is the second.
And then Vertex have shown before that in some of the G551D patients when they did add 661 that they saw a further change, a limited change in sweat, and some further improvements of FEV. There is a debate on those data, whether we still will get that type of improvements when patients have been longer on treatment. That's a possibility.
If we see it that's nice, if you don't see that is not a problem, because it's mainly a safety study. But if you see some activity there, we will report, that's for sure. No problem. Then on the pre-clinical data of Vertex, I can add little. I think broadly we go for triple combinations. We both see that we get, if we add the Kalydeco [Indiscernible] we improve efficacy two, three, four fold pending on the donor [ph]. So I really was pleased with what we've learned this week, and we are convinced that we have a competitive or more than a competitive triple in the reach, and that we're going to develop. I didn't see any reason why we would have to change anything on what I have published this week.
Thank you very much for taking my questions.
We will now take our next question from Matthew Harrison from Morgan Stanley. Please go ahead.
Hi. This is Vikram on for Matthew. Just one question from our side. On filgotinib in Crohn's, are you planning to provide a 25% responder rate, just so that people can compare the dataset with the Celgene data that was released? And if so, when could we expect that?
Okay. Thank you for that question. The [Indiscernible] data on the 25%, honestly we don't have any plans to leave those data. Our KOL [ph] said before the 25% doesn't mean anything. So we don't see why we should add data that doesn't mean anything to our KOL. We are very happy with our 60% improvement score, and are confident that that will translate as well into Phase 3.
And from a sideline, then my observation is that too many people try to interpret studies which were not designed, which are not powered for [Indiscernible]. So whether you report 25% or a 50% improvement, they are simply were not powerful. So you will always get a number that tells you something, but can't tell the full story. And that's why they advise us to take the most difficult hurdle, 50%. If you see something there, it will give you more confidence as you count powers in the Phase 2 for efficacy and for [Indiscernible]. So, no, we don't plan, in short, to remove those data.
Okay. Thank you.
We will now take our question from Debjit Chattopadhyay from Janney. Your line is open. Please go ahead.
Hey, thank you for taking my questions. Let me start with filgotinib. Could you clarify the plans for the 200 milligram dose in TNF naive patients, male TNF naive patients in the US? Will those patients be rolled over into the maintenance portion of the study, or how do we think about them statistically once they finish the safety portion?
Can you please repeat the question, whether I can explain -- so it's the TNF experience in the FINCH 2 study?
Yes. In the IBD program that 200 milligram dose…
Okay, yes. Sorry.
So, the question is in the IBD program, the 200 milligram dose in male patients who are TNF naive; how are we going to account for them statistically? Are they going to move to the maintenance portion of the study, or the initial -- the 10-week induction phase, once they finish the safety portion?
1,789 people have GLPG in their portfolio