Q&A Galapagos CEO talks next steps as coronavirus stalls the biotech's top drug
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 trial 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.
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.
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.
AUTHOR Jacob Bell@realjacobbell
PUBLISHED March 25, 2020 https://www.biopharmadive.com/news/galapagos-ceo-coronavirus-filgotinib-enrollment-pause/574860/