The biotechnology company Galapagos NV recently announced in a press release the results of the DARWIN 1 Phase 2B trial, an ongoing 24 week placebo-controlled, double-blind study to assess the efficacy of the company’s filgotinib in rheumatoid arthritis (RA) patients at three different doses (50, 100 and 200 mg) in a once or twice per day regimen.
RA is an autoimmune disease that causes chronic inflammation and pain in the joints and other parts of the body due to an overreaction of the body’s own immune system. Filgotinib is a selective inhibitor of JAK1 (Janus kinase 1), a protein enzyme that is involved in the signaling pathways of several pro-inflammatory cytokines, ultimately leading to inflammation.
In total, 594 individuals were enrolled in the DARWIN 1 Phase 2B trial. All participants had moderate to severe rheumatoid arthritis and an insufficient response to standard treatment with methotrexate (one of the most effective commonly used drugs for arthritis). Patients received filgotinib or placebo, along with the standard methotrexate treatment, and were followed up for 12 weeks. DARWIN 1’s results for the full 24-week period are expected to be available in the middle of the year.
Researchers found that filgotinib was well tolerated and that after 12 weeks of treatment, RA patients showed an improvement in disease-related symptoms. In terms of ACR (American College of Rheumatology) score, a percentage that indicates how much an individual’s RA has improved, patients under filgotinib treatment had a statistically significant improvement of up to 80% in ACR20 score (the defined primary endpoint of the trial that refers to a 20% improvement) in comparison to the placebo group. ACR50 scores were achieved with all three doses tested with no significant differences between once or twice daily regimens. Patients reported a significant improvement in disease activity as early as one week after starting the treatment.
“The current data with this oral drug spell hope for a potential future treatment option that combines fast onset of action and ease of administration. I am particularly impressed by the rapid improvement reported by the patients,” said Prof. René Westhovens from the University of Leuven, Belgium and Principal Investigator for DARWIN 1.
“I am very pleased to see that filgotinib treatment in DARWIN 1 one of the largest Phase 2 studies in RA to date shows consistent efficacy with fast onset of action. Its selective inhibition of JAK1 also leads to a differentiated safety profile as measured by an improvement in hemoglobin and overall lipid profile. Today’s results with 12 weeks’ treatment with filgotinib met the key efficacy endpoints and are in line with what Galapagos showed in two previous 4-week studies in RA patients. Based on these 12-week results in RA we believe that filgotinib has a promising future to address a significant medical need. We look forward to seeing the DARWIN 2 monotherapy results in just a few weeks” concluded Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.