The future of clinical trials and combination therapy
Vincent Cottin and Luca Richeldi discuss the future of clinical trials and combination therapy for IPF
VC: Luca, it seems that with two drugs available now we have entered a new era in the treatment IPF. So, we're really interested to know how you see the future clinical trials, which ones are being prepared right now?
LR: There is a little bit of discussion on how do we move forward from here, so it’s a mix of excitement - yes we have new drugs - and of fear - how do we move forward from here. But I think we need to consider two things:
1. Other areas have been here before. If just we’ve a look at pulmonary hypertension or cancer, they have first drugs approved and then they get the further drug. So, we’ll move forward. But clearly, there are some priorities now.
So, the first priority will be to understand if these two drugs, they may work together. And to do this we will need properly designed clinical trials exploring the pharmacokinetics and the pharmacodynamics of the two drugs combined and then the safety. So, I think this is a very promising area but we need properly designed and carefully planned studies.
The second area is the placebo arm is not an option anymore, right, I think you agree. And that means that future clinical trials for new drugs will be having a comparator arm which would be the standard therapy. So, it will be add-on or head-to-head trials. This is a bit complicated, the design of the clinical trials, in particular in terms of the primary endpoint, but we should not be scared about that, because we have been there before and will provide our patient with one more option.
The first thing that we need to be mindful of, is that the testing the approved treatments for IPF in other lung disease, non-IPF but ILD is also priority. So, IPF is the prototype of fibrotic lung disorders but, as you know, there are many other fibrotic lung disorders which had a huge unmet medical need, because basically we don't have any drug approved there. So, I’m thinking about connective tissue disease associated ILD or chronic HP or NSIP or all of these fibrotic disorders for which now, currently, we use off-label therapies. So, this is the third area for future clinical trials, in that area probably placebo-controlled trials will still be feasible and I think, I'm almost sure, that there will be the next expansion also for the approved drugs for IPF.
VC: So, it seems that combination therapy is important in these patients, that's an important part of the clinical research.
LR: I think it is very important because if you look at asthma, COPD, lung cancer, pulmonary hypertension, they are all combination therapies. So, I think that in some years we will see combination therapies moving forward and coming onto IPF.