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Galapagos Initiates 3 Phase II Studies for Filgotinib

Zacks Equity Research

Galapagos NV GLPG announced that it has initiated three new phase II Proof-of-Concept studies evaluating its pipeline candidate filgotinib in Sjogren's syndrome, ankylosing spondylitis (AS), and psoriatic arthritis. Galapagos and Gilead Sciences, Inc. GILD have partnered for the global collaboration, development and commercialization of filgotinib in inflammatory indications.

Galapagos’ share price shows that the company has outperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock returned 34.4% compared with industry’s gain of 3.3%.

The phase II study evaluating filgotinib in Sjögren's syndrome will have about 140 adult patients enrolled. The patients will receive either filgotinib, placebo or two other investigational regimens administered once daily for up to 48 weeks. The primary endpoint will be the percentage of patients on treatment fulfilling protocol-specified clinical response criteria at week 12. The Sjogren's study is being led by filgotinib collaboration partner Gilead.

The second TORTUGA phase II study will evaluate filgotinib in adult patients with moderate to severe active ankylosing spondylitis. About 100 patients are expected to be randomized in the study in a 1:1 ratio to receive 200 mg q.d. or placebo q.d. administered for 12 weeks. The primary goal of TORTUGA will be to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of AS, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12.

The third phase II study, EQUATOR, will evaluate filgotinib in adult patients with moderately to severely active psoriatic arthritis. The main objective of EQUATOR will be to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of psoriatic arthritis, as assessed by the American College of Rheumatology 20% improvement score (ACR20) at Week 16. Additionally the study will also show the effects of filgotinib on the skin manifestations (psoriasis) as well as other domains like fingers (dactylitis), tendon insertions (tendinitis), spine involvement (spondylitis) and nail involvement.

The study results are expected to show whether filgotinib can impact signs and symptoms of these three disease areas.

Galapagos is a clinical-stage biotechnology company, and its pipeline comprises a pipeline of phase III, phase II, phase I, pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Filgotinib is the lead candidate of the company and is currently undergoing phase III studies in rheumatoid arthritis, and in Crohn’s disease, and a phase IIb/III study in ulcerative colitis.

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Zacks Rank & Stocks to Consider

Galapagos currently carries a Zacks Rank #2 (Buy). Other favorable stocks in the health care sector include Heska Corp. HSKA, Retrophin, Inc. RTRX. Both the companies carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price increased 43.1% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%. 

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