@NielsjeB: Galapagos wil GLPG1690 binnen beslissende fase IPF studies als add-in en stand alone (Monotherapy) onderzoeken.
Zie onder.
In CC-call na de geweldige FLORA scores binnen IPF tot twee keer toe antwoord van CMO.
(1) Christopher N. Marai - Nomura Securities Co. Ltd., Research Division - MD and Senior Analyst
And then just thinking about the potential next trials and potential arms. Would you be looking at trying this on top of currently approved therapeutics for IPF? Does that make sense mechanistically? Do you expect to see synergies? How should we think about the potential for this to be used in combination with currently available treatment?
Walid Abi-Saab - Galapagos NV - Chief Medical Officer
"Sure. Thanks, Piet. Yes, I think you have to follow both the science and the unmet medical need. As you heard from Onno, this is a disease that's pretty severe, about -- the median survival is about 2 to 5 years after diagnosis. So you have to first evaluate it as quickly as possible on top of --
but at the same time, I think our data and the initial trial were as a stand-alone. So I think going forward, it will robustly evaluate both populations.
That's kind of how we're thinking about it right now, whether that will be done in the same trial or on 2 separate trials remains to be decided. But
again, I think it will be driven mostly by the data and the unmet medical needs".
(2) Vamil Kishore Divan - Credit Suisse AG, Research Division - Senior Analyst
Okay. And my second question is built on one of the earlier questions which is in terms of the future development plans. So what would you -- like, what's your goal here in terms of the late stage trials. Do you need to show superiority over the currently approved agents? Or if you can just show superiority of your placebo with a better safety profile, would that maybe cross-trial comparison suggesting that (inaudible) procedure? Is that sufficient? Just trying to get a sense of how you view the -- what you need to show to be successful commercially.
Walid Abi-Saab - Galapagos NV - Chief Medical Officer
"Yes, I mean, as I mentioned before, I think this is a severe disease. So I think you want to attack it with whatever tools you have. So I think the most
logical step first is to go on top of what's available out there. At the same time, we want to evaluate it as a stand-alone. And then based on these
data, if it makes more sense for the drug to be used by itself because it has a much better efficacy and safety profile, then that's -- ultimately that's
what will guide us to where we need to go and that will be -- the medical care will be shaped by that. If it turns out that actually, patients do benefit
when you add it on top of what's available out there, then I think that's probably the better way to go for the patient. Remember, they have a median survival of 2 to 5 years, so we don't have a lot of time to try things with them. You want to hit it with as much as you can to try and slow the disease progression. We will be guided by the data. I think these are very good questions and ones that we're asking ourselves, but we need
to generate more data with our molecules to be guided as to what will be the best bet".
Tot slot CMO toelichting bij CC Q3 cijfers:
(3) Anastasia Karpova - Kempen & Co. N.V., Research Division - Research Analyst
Three, if I may. Initially, on IPF program, can you all update where you are in the discussions with the regulators concerning Phase II -- Phase III trials.
And would you consider to the combination or monotherapy as well? And do you need to do any breathing studies to open up the IND in the U.S. given that the trial -- the FLORA was conducted in Europe.
Walid Abi-Saab - Galapagos NV - Chief Medical Officer
"So this is Walid. I'm going to take the IPF question first and then turn it over to Piet. So regarding the IPF, we will initiate a placebo-controlled study
on top of the standard of care in the first quarter of 2018. As this study design has already been discussed previously, with both the FDA and EMA.
In addition, we will be discussing additional studies with both agencies in order to complete our registrational programs. And specifically, whether
we need to do any bridging before we go to U.S., the answer is no, we can go straight in the U.S. with the package that we have now".
Ook Prometic gaat voor een Monotherapy studie, naast de add-on studie. Deze laatste studie start ook als eerst, net als wat bij Galapagos het geval zal zijn.