Results

Gilead and Galapagos bag promising PhII data for star immunology drug filgotinib — boosting late-stage focus

Gilead $GILD and its partners at Galapagos $GLPG picked up some “very impressive” mid-stage data for their star immunology drug filgotinib, which handily beat out a placebo in treating psoriatic arthritis. 

Deep into a Phase III program for rheumatoid arthritis, researchers say that the drug collected an ACR20 score of 80% versus 33% for the sugar pill, hitting the primary endpoint. Compare that to Pfizer’s Xeljanz, which was approved for this condition with an ACR20 of 50%. 

The rest of the endpoints also looked good: “The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo (ACR50:  48 percent for filgotinib versus 15 percent, p<0.001; ACR70: 23 percent versus 6 percent, p<0.01).”

Gilead also got a green light from their data monitoring committee in a different study to proceed into the pivotal stage of their trial for ulcerative colitis study, triggering a $15 million bonus for Galapagos.

Gilead faces a myriad of rivals focused on immunology, but the competitive big cap company recently doubled down in the field, allying itself with Verily on a platform tech they plan to use to identify patient subgroups most likely to respond to their therapies.

AbbVie axed a collaboration it had in place with Galapagos for their JAK1 inhibitor filgotinib (GLP0634), saying it preferred to take their in-house program for ABT-494 into Phase III for arthritis. But Gilead, in search of beefing up its late-stage prospects, saw a potential blockbuster in the wind. The big biotech swooped in with a $725 million upfront – including a $425 million equity stake – to partner on the drug. And Gilead added $1.35 billion in potential milestones.

“The data from the EQUATOR study are very impressive and indicate that filgotinib has the potential to have a significant effect on signs and symptoms of psoriatic arthritis, a condition where there is still a high unmet medical need,” said Philip Mease, the director of rheumatology research at Swedish-Providence Saint Joseph Health Systems.


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