Galapagos NV (GLPG +5%) is up on modestly higher volume in early trading. The bullish action is being stoked by increased optimism with Crohn's disease (CD) candidate filgotinib after Celgene (CELG +0.8%) released early-stage data on its CD candidate GED-0301.
Yesterday, Celgene announced Phase 1b data which showed a 67% clinical response rate and 48% remission rate in patients treated with GED-0301 for 12 weeks. Clinical response was defined as at least a 100 point drop in a CD symptom scale called Crohn's Disease Activity Index (CDAI) while clinical remission was defined as a CDAI score less than 150. Patients with active CD have CDAI scores of 220 - 450. A Phase 3 study is currently recruiting patients. According to ClinicalTrials.gov, the estimated completion date is April 2022.
A Phase 2 study, FITZROY, showed a statistically valid proportion of patients receiving filgotinib for 10 weeks achieved clinical remission compared to placebo (48% vs. 23%; p=0.0067). The proportion of clinical responders (60% vs. 41%; p=0.0386) also favored filgotinib. Both endpoints were based on the same CDAI metrics as Celgene. A Phase 3 study in adults with moderately to severely active Crohn's should commence shortly. According to ClinicalTrials.gov, the estimated study completion date is December 2019. It is being developed with collaboration partner Gilead Sciences (GILD +1.4%).
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