Galapagos DARWIN 1 And 2 Studies Have Completed 24 Weeks Of Treatment
• Last of 886 enrolled rheumatoid arthritis (RA) patients have completed the 24 week visit
• Topline results from final analyses expected to be released in July and August 2015
Mechelen, Belgium; 10 June 2015 - Galapagos NV (Euronext & NASDAQ: GLPG), a clinical stage biotechnology company focused on developing novel mode of action medicines, announces 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."
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. In the field of inflammation, AbbVie and Galapagos signed a collaboration agreement for the development and commercialization of filgotinib. Filgotinib is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's disease. Galapagos reported good activity and a favorable safety profile at 12 weeks in both the DARWIN 1 and 2 trials in RA. AbbVie and Galapagos also signed a collaboration agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical candidate stage. GLPG1205, a first-in-class inhibitor of GPR84 and fully-owned by Galapagos, is currently being tested in a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690, a fully proprietary, first-in-class inhibitor of autotaxin, has shown favorable safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic pulmonary fibrosis. The Galapagos Group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More info at www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
ir@glpg.com
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• Topline results from final analyses expected to be released in July and August 2015
Mechelen, Belgium; 10 June 2015 - Galapagos NV (Euronext & NASDAQ: GLPG), a clinical stage biotechnology company focused on developing novel mode of action medicines, announces 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."
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. In the field of inflammation, AbbVie and Galapagos signed a collaboration agreement for the development and commercialization of filgotinib. Filgotinib is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's disease. Galapagos reported good activity and a favorable safety profile at 12 weeks in both the DARWIN 1 and 2 trials in RA. AbbVie and Galapagos also signed a collaboration agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical candidate stage. GLPG1205, a first-in-class inhibitor of GPR84 and fully-owned by Galapagos, is currently being tested in a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690, a fully proprietary, first-in-class inhibitor of autotaxin, has shown favorable safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic pulmonary fibrosis. The Galapagos Group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More info at www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
ir@glpg.com
Help employers find you! Check out all the jobs and post your resume.