Galapagos to advance filgotinib to Phase 3

Friday, September 25, 2015

Galapagos NV announced  that the Company will be moving filgotinib, its highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016.  Filgotinib has shown best-in-class efficacy and safety in the DARWIN Phase 2B studies in rheumatoid arthritis and is now fully owned by Galapagos. 

Galapagos has demonstrated  that high selectivity for JAK1 results in excellent efficacy and safety in rheumatoid arthritis patients.  Based on our own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is three-fold more JAK1 selective than ABT-494.  Galapagos reported best-in-class efficacy and safety in 24-week Phase 2B studies in 877 patients with filgotinib.  Furthermore, Galapagos has  more than 700 patient-years of treatment experience with filgotinib in RA patients, of which more than 500 years at the highest 200 mg dose, all with  a clean safety profile consistent with JAK1 inhitbition: filgotinib showed a clear dose dependent increase in hemoglobin concentration without any impact on NK cells and lymphocyte counts.

"We see a rapid path forward in development for filgotinib, which we will be taking into Phase 3.  Galapagos is currently in advanced discussions with a substantial number of large pharma  companies to partner filgotinib.  We anticipate starting Phase 3 in rheumatoid arthritis with filgotinib early in 2016 and we are expecting data from our Phase 2B FITZROY study with filgotinib  in Crohn's disease by yearend,"said Onno van de Stolpe, CEO of Galapagos.   

On efficacy, Galapagos consistently has reported ACR scores using the most conservative NRI approach.  The table below shows the ACR scores for the DARWIN 1 study at 24-weeks on the LOCF basis, for comparison purposes :

 

DARWIN1 (MTX-IR)

ACR20

ACR50

ACR70

50mg, once-daily

61*

35**

22*

100mg, once-daily

74***

54***

38***

200mg, once-daily

78***

55***

31**

25mg, twice-daily

62*

38**

22*

50mg, twice-daily

66*

38**

25*

100mg, twice-daily

87***

62***

43***

placebo

45

16

9

* p< 0.05 vs. placebo; ** p<0.01 vs. placebo; *** p<0.001 vs. placebo;  ACR scores based on LOCF analysis

AbbVie notified Galapagos of termination of the agreement on 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.  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 in both the DARWIN 1 and 2 trials in RA.  In the field of cystic fibrosis, AbbVie and Galapagos signed a collaboration agreement 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

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