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Filgotinib meets primary endpoints at 12 weeks in phase 2B study of patients with RA
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Galapagos has announced its Janus kinase-1 inhibitor, filgotinib, met its primary and other key efficacy endpoints at 12 weeks in a phase 2B rheumatoid arthritis study.
Named DARWIN 1, the study is an ongoing, double-blind, placebo-controlled, 24-week evaluation of three daily dose levels of filgotinib taken once or twice daily in combination with methotrexate. The study includes 594 patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate.
At 12 weeks of treatment with a daily dose of 200 mg, the study’s primary endpoint - a 20% improvement by American College of Cardiology criteria (ACR20) - was observed in up to 80% of participants, and patients reported improvements after 1 week of treatment, according to a company press release. Additionally, statistically significant improvements in ACR50 scores were achieved at all dose levels. Hemoglobin was also shown to increase, and the total cholesterol to HDL ratio improved with dose.
In addition to patient reports of improvements, the disease activity score in 28 joints (DAS28-CRP) improved within the first week of dosing compared with placebo, and the change increased with dose, according to the release
Safety concerns, which include three incidents of serious infection, prompted 1.7% of patients to discontinue the trial. The remaining side effects are being withheld to keep participants blind to potential bias.
Filgotinib is the first Janus kinase inhibitor (JAK) to selectively target JAK 1 instead of JAK 2 or JAK 3, according to the release.
The company anticipates a report of the full 24-week results of DARWIN 1 by mid-2015, the release stated.
Reference: www.glgp.com.