Galapagos and Gilead have reported positive results from a Phase III trial testing Galapagos’ lead drug candidate in patients with rheumatoid arthritis.
The clinical trial recruited patients with rheumatoid arthritis that did not respond or were intolerant to three or more biological antirheumatic drugs. After 12 weeks of treatment, 57% of patients in the lower dose and 66% in the higher dose groups achieved the level of response set as a primary endpoint. The results for the placebo group were significantly lower.
The drug candidate, called filgotinib, is being developed by Galapagos and Gilead as a treatment for 11 different diseases caused by inflammation. The rheumatoid arthritis, ulcerative colitis and Crohn’s disease programs are the most advanced, currently in Phase III trials. Another program, in ankylosing spondylitis, yielded positive results in a Phase II trial last week.
The inflammation market is huge, expected to reach over €100Bn by 2020. The world’s best-selling drug, Humira (adalimumab) is indicated against multiple inflammatory conditions, including rheumatoid arthritis. By targeting patients that do not respond to biological drugs like Humira, Galapagos could have a competitive advantage in this market. However, it will be facing competition from its previous partner AbbVie.
Before the partnership with Gilead, Galapagos was working with AbbVie in the development of filgotinib. However, the big pharma walked out of their agreement in 2015 and is now developing its own candidate drug for rheumatoid arthritis. AbbVie’s drug candidate, upadacitinib, which has a similar mechanism of action to filgotinib’s, also yielded positive Phase III data in April.
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