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Gilead, Galapagos Spondylitis Drug Meets Primary Endpoint


Gilead Sciences, Inc. GILD and partner Galapagos NV GLPG announced positive results from the randomized, placebo-controlled phase II study, TORTUGA, on experimental candidate — filgotinib.

The trial is evaluating the safety and efficacy of filgotinib, an investigational, selective JAK1 inhibitor, in adult patients suffering from moderately to severely active ankylosing spondylitis (AS).

A total number of 116 patients were randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12 weeks.

The results show that patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), which is the primary endpoint, at week 12 with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001). In addition, the results show that more patients receiving filgotinib have achieved an ASAS20 response compared to those treated with placebo (76% versus 40%).

Filgotinib was generally well tolerated. The detailed results will be presented at a future scientific conference.

We remind investors that Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications in 2016. Apart from the TORTUGA trial, the candidate is also being evaluated in the ongoing phase III program, FINCH in rheumatoid arthritis, the phase III trial, DIVERSITY in Crohn’s disease (also small bowel and fistulizing Crohn’s disease phase II studies) and the phase III SELECTION trial in ulcerative colitis.

Meanwhile, the successful development and commercialization of the candidate will boost growth for Gilead. Gilead’s stock has gained 4% in the year so far compared with the industry's decline of 3%.

Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to help its top line.

Gilead is intending to foray into the nonalcoholic steatohepatitis (NASH) and inflammation market with late-stage candidates, selonsertib and filgotinib, respectively.

During the first quarter of 2018, Gilead announced an agreement with Sangamo Therapeutics, Inc. SGMO to use Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology.

However, Gilead will have to generate substantial revenues from its HIV franchise and Yescarta 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.

Zacks Rank

Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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