Gilead, Galapagos clear another PhII hurdle for filgotinib, but can they hope to catch up with Novartis’ Cosentyx?

Gilead and Galapagos have cleared another hurdle in a broad-ranging program to advance filgotinib into the market as a blockbuster candidate. But this latest achievement still leaves them way behind a surging Novartis in a packed field of rivals.

Walid Abi-Saab

Researchers say that the drug hit clearly positive endpoints for moderate to severe active ankylosing spondylitis. That includes the primary endpoint, which took a look at a disease activity score at week 12. There they saw a drop from baseline of 1.5 compared to 0.6 for the control arm. There was also a 76% ASAS20 response for the drug arm compared to 40% in the placebo group.

Gilead picked up rights to filgotinib after AbbVie abandoned it to pursue their in-house program for a rival drug. They’re all playing catch-up to Novartis’ Cosentyx, which has grabbed a slate of approvals as they move their IL-17 drug through the chess board of indications, including ankylosing spondylitis, plaque psoriasis and psoriatic arthritis. And the Gilead/Galapagos team is in a massive Phase III program for autoimmune diseases after hitting their marks in a range of mid-stage studies like this.

This is not just a market waiting to happen, though.

Novartis recently launched a head-to-head AS study of its Cosentyx against their biosimilar, the granddaddy of the big biologics. The pharma giant also recently launched a pilot study on the bone health of ankylosing spondylitis as they move to protect the franchise — part of a broad ranging effort to go big with this blockbuster.

The crowded autoimmune field also includes Eli Lilly’s Taltz, Siliq from the biotech formerly known as Valeant, Dupixent from Sanofi and J&J and guselkumab from J&J.

“We are excited to see that filgotinib showed strong activity across a wide range of parameters relevant for ankylosing spondylitis and was well tolerated in TORTUGA, which reinforces previous findings about the activity and tolerability profile of filgotinib in multiple inflammatory conditions,” said Walid Abi-Saab, the chief medical officer at Galapagos.

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