Gilead and Galapagos Report Results of Filgotinib in P-IIb/III SELECTION Study for Moderately to Severely Active Ulcerative Colitis

Gilead and Galapagos Reports Results of Filgotinib in P-IIb/III SELECTION Study for Moderately to Severely Active Ulcerative Colitis

Shots:

  • The P-IIb/III SELECTION study involves assessing of filgotinib (200/ 100mg) vs PBO in 1,348 biologic-naïve & biologic-experienced patients in a ratio (2:2:1) with mod. to sev. UC. The SELECTION study consists of 2 induction trials and a maintenance trial
  • Filgotinib (200mg) achieved all its 1EPs inducing clinical remission @10wks. in biologic-naïve & experienced patients (26.1 % vs 15.3% & 11.5% vs 4.2%) and maintaining clinical remission @58wks. (37.2% vs 11.2) while in 100mg arm, clinical remission @58wks. (23.8% vs 13.5%) and did not achieve clinical remission @10wks.
  • Filgotinib is an investigational, oral, selective JAK1 inhibitor and is currently under US FDA, EMA and MHLW’s review the for the treatment of RA

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