Gilead & Galapagos Announce Positive Data On Filgotinib

Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV (NASDAQ:GLPG) announced that the phase II study, EQUATOR, on pipeline candidate, filgotinib achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20 percent improvement score (ACR20).

The EQUATOR trial, initiated by Galapagos in April 2017, is a multicenter randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active psoriatic arthritis.

The data from the study depicted an ACR20 response of 80% for filgotinib versus 33% for placebo. Additionally, the ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib than placebo. Filgotinib was generally well-tolerated in the trial and no new safety signals were observed. However, there was one serious infection in the filgotinib group where a patient who experienced pneumonia with a fatal outcome and one other patient receiving filgotinib developed herpes zoster.

Both the companies plan to report the detailed results from the EQUATOR trial at a future scientific conference.

Concurrently, Gilead and Galapagos also announced that an independent Data Monitoring Committee (DMC) conducted a planned interim futility analysis of the phase IIb/IIII study, SELECTION, on filgotinib for the treatment of ulcerative colitis. The analysis was conducted after 350 patients completed the induction period in the phase IIb portion of the study. The DMC recommended that the study should go on as planned into phase III at both the 100 mg and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients. The multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients, with moderately to severely active ulcerative colitis was initiated by Gilead in late 2016. Consequently, Gilead will pay $15 million to Galapagos for this progression from phase II to phase III in the SELECTION trial. The trial will enroll a total of 1,300 patients, targeted to be randomized to receive filgotinib 100 mg, 200 mg, or placebo once-daily administered for 58 weeks. The primary objective of SELECTION is to evaluate the efficacy of filgotinib as compared to placebo in establishing EBS (endoscopy, bleeding, stool) remission at Week 10.

Both Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The candidate is also being evaluated in the ongoing phase III program, FINCH in rheumatoid arthritis, the phase III trial, DIVERSITY for Crohn’s disease (also small bowel and fistulizing Crohn’s disease phase II studies) among others.

Given the persistent decline in HCV sales, Gilead is looking to newer avenues to help its top line. Gilead’s stock has lost 8.2% in the last six months as against the industry''s loss of 8.1%.

Gilead’s HCV franchise witnessed slowdown across key markets, including the United States and Europe, reflecting lower sales of Harvoni and Sovaldi as a result of competitive and pricing pressure. The franchise saw a significant plunge in sales due to new competition and fewer patient starts. Pricing has largely stabilized and market share will stabilize by mid-2018, while patient starts are expected to decline further. We note that Harvoni, Sovaldi and Epclusa face competition from AbbVie’s (NYSE:ABBV) Viekira Pak and Mayret, and Merck’s (NYSE:MRK) Zepatier among others.

Gilead is looking to solidify its presence in the gene therapy space. The initial uptake of Yescarta is also encouraging. Gilead is also intending to foray into the NASH market with pipeline candidates — selonsertib and filgotinib.

Zacks Rank

Gilead currently carries a Zacks Rank #3 (Hold).

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