Gilead Sciences Inc. (GILD) and Galapagos NV (GLPG) initiated a Phase 3 trial for their Crohn’s disease drug, filgotinib.

As a result, Gilead will pay a $50 million milestone payment to Galapagos. (For more, see Gilead May Not Acquire Galapagos, For Now.)

The JAK1-selective inhibitor filgotinib is a drug the two companies are developing to treat inflammatory disease like rheumatoid arthritis, Crohn's disease, and ulcerative colitis. (For more, see Gilead Fatty Liver Drug Advances to Phase 3.)

The trial will evaluate the efficacy and safety of the once-daily drug filgotinib drug in two different doses of 100 mg and 200 mg versus a placebo in 1,300 patients who have moderate to severe active Crohn's disease. 

The Phase 3 study will include patients who failed treatment with a biological therapy like Johnson & Johnson’s (JNJ) Remicade and Takeda’s Entyvio.

Competitive Head Start

The timely launch of the Phase 3 trial, which is expected to conclude in late 2019, gives Gilead and Galapagos a lead over AbbVie Inc.’s (ABBV) Crohn's disease drug, ABT-494.

In 2012, AbbVie and Galapagos signed a $1.4 billion deal to develop and commercialize filgotinib, but AbbVie dumped the deal in September 2015 to develop its own JAK1 inhibitor therapy, ABT-494. However, ABT-494 currently remains in Phase 2 trials.

Its current head start and an eventual approval, if secured, will make Gilead a leader in Crohn’s disease treatment using JAK1 inhibitors, giving it the first-mover advantage.

However, Gilead’s drug lags ABT-494 for rheumatoid arthritis treatment, as ABT-494 started Phase 3 trials in January 2016, while filgotinib started trials in August.

Filgotinib will also be studied in Phase 2b/3 trials to treat ulcerative colitis over the next few weeks. Gilead reported disappointing data from its other ulcerative colitis drug, GS-5745, which resulted in a trial suspension. (For more, see Gilead Ends Bowel Disease Treatment Trials.)

Filgotinib will help Gilead fill the void with a potential treatment for multiple indications. (For more, see Gilead Dumps GlobeImmune Deal.)