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Gilead, Galapagos report competitive numbers for first big PhIII readout for filgotinib in rheumatoid arthritis

Gilead $GILD and its partners at Galapagos $GLPG offered their first cut of Phase III data for filgotinib, their late-stage candidate for disrupting the rheumatoid arthritis market. And while they may have come in numerically a little behind their big rival at AbbVie, researchers seem to have gained a good safety profile and some competitive numbers that help justify Gilead’s $725 million upfront nearly 3 years ago.

John McHutchison

Looking at a snapshot of the data, 100 mg filgotinib hit a 57.5% mark for ACR20 at 12 weeks and 66% for 200 mg. At the 24 week mark, that translated to 54.9% and 69.4%. The clinical remission rate was 25.5% and 22.4% at 12 weeks, 26.1% and 30.6% at 24 weeks.

That was all much better than the placebo arms in this study — hitting the primary and the key secondaries in sight. Filgotinib, though, is the drug that AbbVie $ABBV abandoned to stick with upadacitinib (ABT-494), which in one Phase III hit with 71% of patients achieving ACR20 and 29% achieving clinical remission at week 12.

Gilead’s shares jumped 2.3% on the news in after-market trading while Galapagos saw its stick surge 18% on Wednesday.

This isn’t a head-to-head study, of course, but these days it may as well be. 

Upadacitinib, like other JAK inhibitors such as Eli Lilly’s baricitinib, has had some safety issues to contend with. In this study of filgotinib, the companies gave themselves high marks on safety, with no trial deaths to report; 3.4, 5.2 and 4.1% of the patients in the placebo, 100mg and 200mg groups reporting a serious adverse event. There was “one case of non-serious retinal vein occlusion in the filgotinib 200 mg group and no reports of deep venous thrombosis or pulmonary embolism.”

There were two big MACE events, but they were split between the drug and placebo arms.

Leerink’s Geoffrey Porges sized up the press release and says this one could be a game changer, with an improved 80% chance of success at the FDA.

At least based on the companies’ press release last night, this hypothesis is indeed valid and supports the notion that while filgotinib may not be the first of these drugs to market (likely the last), it might be the best.

Jefferies’ Michael Yee was quick to remark:

The good news is this is the first positive study and helps to de-risk the initial readouts for the franchise and looks pretty clean. We see this as a modest but good catalyst for GILD given recent stock performance over the last few months and some frustrated investor sentiment. The next major readouts are in H1:19, although the key bigger picture readout that Street will want to know in time is the Phase II/III UC male toxicity study which is still enrolling, and GILD is working hard to accelerate enrollment which may include opening it up to other indications and lots more sites.

“These initial Phase III data support the potential of filgotinib, in combination with select disease modifying drugs, to help patients with active rheumatoid arthritis who do not adequately respond to current biologic disease modifying agents,” says Gilead CSO John McHutchison. “These data are particularly encouraging as we look ahead to Phase 3 results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”


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