Filgotinib fails to fly despite ankylosing spondylitis boost

A win for Galapagos and Gilead’s filgotinib in a mid-stage ankylosing spondylitis trial has not been enough to whet investors’ appetites ahead of the main event: phase III data in the Jak inhibitor’s lead indication, rheumatoid arthritis. In fact, Galapagos’s stock sank 2% today after it reported that the Tortuga study had met its primary endpoint, improvement in the AS disease activity score at 12 weeks versus placebo. A case of “non-serious” deep venous thrombosis might not have done much for the theory that filgotinib has a cleaner safety profile than some of the other Jak inhibitors, but Galapagos stressed that the adverse event had occurred in a patient with an inherited risk for thrombosis. Another patient in Tortuga was hospitalised for pneumonia but recovered. Safety will be paramount in the upcoming Finch 2 study in rheumatoid arthritis if filgotinib, which is set to become the fourth Jak inhibitor to market, is to have a chance of competing. The ankylosing spondylitis space is slightly less crowded, but the Galapagos and Gilead project is behind Pfizer’s Xeljanz, which is already in phase III; Abbvie’s upadacitinib, meanwhile, is in a phase II study in this indication.

Tortuga trial data
Endpoint Filgotinib Placebo  P value
Change in AS Disease Activity Score at week 12* -1.5 -0.6 <0.0001
ASAS20 response 76% 40% <0.0001
*Primary endpoint. Source: company press release.

 

Filgotinib's shots on goal
Indication Phase  Trial Status 2024e sales ($m)
Rheumatoid arthritis III Finch 2, NCT02873936 Data due Q3 2018 1,064
Crohn's disease III Diversity, NCT02914561 Primary completion Nov 2019 166
Ulcerative colitis II/III Selection, NCT02914522 Proceeding to phase III portion after interim analysis 49
Ankylosing spondylitis II Tortuga, NCT03117270 Met primary endpoint Sep 2018 -
Psoriatic arthritis II Equator, NCT03101670 Met primary endpoint May 2018 -
Source: EvaluatePharma, Clinicaltrials.gov.

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