At the heart of a $5 billion deal between Gilead Sciences and the Belgian biotech Galapagos is an experimental drug that regulates the immune system.
Clinical research has found the drug, known as filgotinib, to be an effective treatment for rheumatoid arthritis, enough so that Gilead in December asked the Food and Drug Administration to approve it. As the companies await the agency's decision, they're investigating filgotinib across other immune-related diseases. A federal database of clinical trials shows 14 ongoing studies testing the drug in Crohn's disease, ulcerative colitis and psoriatic arthritis, among other conditions.
The new coronavirus, however, has prompted Gilead and Galapagos to pause enrollment for more than half of these trials.
The decision was made to protect patients, according to Galapagos CEO Onno van de Stolpe. Since filgotinib acts as an immunosuppressant, blocking an important protein called JAK1, the companies agreed it wasn't appropriate to give the drug to more patients as COVID-19, the disease caused by the new coronavirus, continues to spread globally.
BioPharma Dive spoke with van de Stolpe about the enrollment pauses and the next steps for filgotinib, both in the clinic and, potentially soon, in the market.
The following conversation has been edited and condensed for clarity.
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.
Filgotinib trials that have paused enrollment
|Study name||Phase||Indication||Target enrollment||Est. primary completion date|
|Penguin 1||3||Psoriatic arthritis||1,001||February 2022|
|Penguin 2||3||Psoriatic arthritis||390||September 2021|
|MANTA-RAy||2||Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis||250||January 2021|
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.