Thanks for the addition NielsjeB. It has an impact, but it's a limited impact. It's a reality of life.
Onno and his team has always been very ambitious and setting the bar high.
The following conversation has been edited and condensed for clarity (March 25, 2020).
BIOPHARMA DIVE: You released a short update on March 22 about COVID-19
and its effects on filgotinib studies. Is there any more you can add about that
decision?
VAN DE STOLPE: Gilead decided that, due to the safety for patients, it would be
better to stop recruitment in the filgotinib studies. Filgotinib is a JAK1 inhibitor — and,
in inhibiting JAK1, you are compromising the immune system. We'll pick it back up
when things get back to a more normal situation.
This impacts especially the Crohn's study and some of the smaller Phase 2 studies. It
does not impact the ulcerative colitis study because [enrollment] is completed and, of
course, rheumatoid arthritis neither because that study is completed. So it has an
impact, but it's a limited impact. It's a reality of life.
We have other studies ongoing that we haven't stopped. There, we have the
Roccella study, which is fully recruited and is reading out in the second half of the
year.
And then the important one is the ISABELA study for GLPG 1690 in ideopathic
pulmonary fibrosis. That study is still continuing to recruit, although these patients are
also at risk, and even more at risk because they've got reduced lung function. This is
a deadly disease — when you have IPF, you have a window of three to four years.
So the need to find something that stops the progression of the disease is very high,
and we see a continuous interest of doctors to screen patients to see if they're
eligible for inclusion in the trial.
Although there's a slowdown in those trials, we don't expect recruitment to stop there.
Of course, visibility is extremely limited, so things could change by the hour, by the
day.
You said the enrollment pauses had to do with the safety of patients who you
expect would be enrolled in these trials. Is that because of age, or is it due to
concerns about the drug's effects on the immune system?
VAN DE STOLPE: These are sick patients, and with sick patients in general their
immune system is not very high.
In Crohn's, it's a much younger population than in rheumatoid arthritis — rheumatoid
arthritis is 60, 65 years, and in Crohn's it can be 30, 40. It's not that you have an
elderly population, but [rather that] you have a weakened population because of the
disease. Then to come in with an immunosuppressant drug, that is not ideal in the
time of COVID-19.
Some of these paused studies have quite large estimated enrollments. Were
you close to completing enrollment on any of them, or was completion at least
several months away?
VAN DE STOLPE: Only the Crohn's study is that large, because the ulcerative colitis
study is already fully recruited. In the Crohn's study, we still need quite a bit of
patients, but it has been slow recruiting anyway. It's difficult to find the right Crohn's
patients, and it'll just be on hold until we can pick it up again.
Is there any timeline for how long it might take before Galapagos resumes
enrollment into any of these studies?
VAN DE STOLPE: No. If you see what's happening in the U.S. at the moment,
everything is closing down. We have no view on what's going to happen over there. I
don't think anybody can make a sensible calculation of when they'll be back. We see
some stabilization in Italy and we see Asia coming back up to action. But yeah, the
U.S. is just starting.
Before the trials were paused, what were the conversations like with your
partner Gilead?
VAN DE STOLPE: These trials are run by Gilead, so it's their decision to do this. Of
course there was a discussion ... but we agree with [how] Gilead's taking the initiative
and action.
Gilead filed filgotinib in the U.S. late last year. Are there any concerns about the drug's review timeline at the FDA?
VAN DE STOLPE: That's a good point. For now, we haven't heard any delays. There aren't any changes in timing. They are working from home, but if a number of these reviewers get ill, for example, it might have an impact on the timelines. If you look at what happened during previous crises, like a government shutdown or 9/11, the FDA didn't stop reviewing. So we don't anticipate a delay.
Filgotinib trials are halting enrollment because of patient safety concerns, but one could imagine that, if the drug is comes to market, those concerns would still be there. Are you having conversations about the challenges of giving this drug to patients in the rheumatoid arthritis community?
VAN DE STOLPE: I'm sure those discussions are being held.
All the drugs in rheumatoid arthritis are challenging the immune system. So you are one among a class. I don't think that's going to be the big change. People who have disease want to be treated — and [though] there's an additional risk of infections, it's clear they are aware of that. I don't know if people with milder forms of rheumatoid arthritis are stopping using drugs. I really can't tell. But if you have severe rheumatoid arthritis, you will use a drug. And then you have to be extremely careful not to get infected with this virus, that's for sure.