Gilead & Galapagos Announce Positive Data On Arthritis Drug
Zacks Investment Research | Mar 28, 2019 09:13PM ET
Gilead Sciences, Inc. (NASDAQ:GILD) and partner Galapagos NV (NASDAQ:GLPG) announced encouraging interim safety information from four studies on experimental candidate, filgotinib for the treatment of rheumatoid arthritis (RA).
These include 24-week results of the ongoing phase III FINCH 1, 2, and 3 trials, and updated week 156 safety data from the phase IIb DARWIN 3 long-term extension study in patients with RA.
The phase III study, FINCH 1 evaluated filgotinib in comparison with AbbVie, Inc. (NYSE:ABBV) ’s Humira or placebo on a stable background dose of methotrexate (MTX) in patients with prior inadequate response to methotrexate. The study achieved its primary endpoint for both doses of filgotinib. Filgotinib 100 mg and 200 mg doses demonstrated significantly higher ACR20/50/70 responses compared to placebo in patients with prior inadequate methotrexate response.
FINCH 3 evaluated filgotinib in combination with MTX and as monotherapy in MTX-naïve patients. Filgotinib 100 mg and 200 mg when added to MTX demonstrated significantly higher ACR20/50/70 responses than methotrexate alone. The study achieved its primary endpoint, as higher percentage of patients achieved the primary endpoint of ACR20 response at week 24 for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with only MTX alone.
Meanwhile, DARWIN 3 is an ongoing multi-center, open-label, long-term follow-up safety and efficacy trial of filgotinib in subjects who completed either DARWIN 1 or DARWIN 2. The patients (739) enrolled in the study were suffering from moderate to severe RA and showed an inadequate response to MTX. The safety profile of the candidate was consistent with previous studies.
We remind investors that both the companies entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases. Apart from RA, the candidate is being evaluated in a phase II EQUATOR program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY phase III program in Crohn’s disease and the phase III SELECTION trial in ulcerative colitis.
The successful development and commercialization of the candidate will boost growth for Gilead. The stock has gained 2.8% in the year so far, lagging the industry' s growth of 9.8%.
Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to boost its top line.
However, Gilead will have to generate substantial revenues from its HIV franchise to offset the HCV sales decline. This will be a challenging task for the company with stiff competition from the likes of GlaxoSmithKline (GSK) in the HIV market.
Gilead is intending to foray into the non-alcoholic steatohepatitis (NASH) and inflammation markets with late-stage candidates, selonsertib and filgotinib, respectively.
However, the company recently announced the failure of its late-stage study on selonsertib, involving patients afflicted with compensated cirrhosis (F4) due to NASH.
Gilead also collaborated with Agneus (NASDAQ:AGEN) for the development and commercialization of up to five novel immuno-oncology therapies.
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