Galapagos NV has announced that the last RA patients in its DARWIN 1 and 2 dose finding studies with filgotinib have completed their final visit. This triggers the clinical research organization's process of last 24 week data collection from both studies, to be followed by final database lock and analysis. Galapagos expects to announce topline results in late July (DARWIN 1) and in August (DARWIN 2) 2015.
The last patients in the studies have completed treatment and have now rolled over to DARWIN 3, the open-label, long-term extension study with filgotinib.
Results at 12 weeks
The DARWIN 1 and DARWIN 2 studies both met their primary endpoint at 12 weeks of treatment with the selective JAK1 inhibitor filgotinib. Patients in both studies showed improvements in signs and symptoms of active RA and both studies met key efficacy endpoints at 12 weeks of treatment with filgotinib: statistically significant ACR50 scores were achieved with all dose levels and dose regimens, and statistically significant improvement in DAS28(CRP) was seen within one week. Filgotinib was also well tolerated and showed a differentiated safety profile at 12 weeks in RA patients. Hemoglobin levels increased, consistent with JAK1 selectivity.
Completion 24 weeks
Filgotinib has now been evaluated in a global Phase 2B program (DARWIN 1, 2 and 3) in 886 RA patients. Topline results from 24 weeks' treatment in DARWIN 1 and 2 will include efficacy scores and unblinded lab and safety information.
"We really look forward to the 24 weeks' topline results starting in July," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "After having met the primary endpoint and secondary endpoints in both studies at 12 weeks, with a differentiated safety picture, we eagerly anticipate seeing how well this potential best-in-class profile holds up with 24 weeks' treatment. Knowing that 98% of eligible patients who completed DARWIN 1 and 2 also enrolled in DARWIN 3 gives confidence, as investigators and patients saw benefit in continuing treatment with filgotinib."