Gilead and Galapagos have announced that their oral JAK inhibitor filgotinib has hit its goal in phase III trials in patients with rheumatoid arthritis who have failed on other treatments.
The results are further good news for the partners and their inflammatory conditions contender, which is also being studied in ulcerative colitis, Crohn’s disease and ankylosing spondylitis.
The FINCH 2 trial of filgotinib in adults with moderately-to-severely active rheumatoid arthritis achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) at Week 12.
Filgotinib 100 mg and 200 mg doses achieved significantly higher ACR20/50/70 responses than placebo, with a reading of 57.5% for ACR20 at 12 weeks and 66% for the higher dose, compared with 31.1% for placebo.
The news was a particular fillip for Galapagos, which saw its shares rise 6% on the announcement, with Gilead’s shares also up.
John McHutchinson
John McHutchison, MD, chief scientific Officer, head of research and development at Gilead said the data showed the potential of the drug candidate in combination with other disease modifying drugs to help patients with active RA who don’t respond adequately to current biologics.
“These data are particularly encouraging as we look ahead to phase III results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”
The first JAK inhibitor on the market is Pfizer’s Xeljanz (tofacitinib) and already earns in excess of $1bn a year in RA revenues.
Another player is Lilly’s Olumiant, though this is held back by safety concerns. Analysts are predicting a showdown between filgotinib and AbbVie’s rival, upadacitinib, as the next decisive event in the JAK inhibitor market.
AbbVie looks to have the lead in the race to market, with phase III data in hand showing that upadacitinib is more effective than AbbVie’s $18bn-a-year injectable TNF blocker Humira (adalimumab) in RA when it comes to clinical responses gauged by doctors and patients.
The new results for filgotinib follow close behind positive results in ankylosing spondylitis last week