Upcoming AWS Coverage on Emergent BioSolutions Post-Earnings Results

LONDON, UK / ACCESSWIRE / March 13, 2017 / Active Wall St. blog coverage looks at the headline from Galapagos N.V. (NASDAQ: GLPG) as the Company announced on March 10, 2017, two new Phase-2 studies investigating filgotinib in small bowel Crohn's disease as well as in fistulizing Crohn's disease. These studies are being led by filgotinib collaboration partner Gilead Sciences, Inc. Register with us now for your free membership and blog access at:

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One of Galapagos' competitors within the Biotechnology space, Emergent BioSolutions Inc. (NYSE: EBS), reported on February 24, 2017, its financial results for the quarter and twelve months ended December 31, 2016. AWS will be initiating a research report on Emergent BioSolutions in the coming days.

Today, AWS is promoting its blog coverage on GLPG; touching on EBS. Get all of our free blog coverage and more by clicking on the link below:

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The Study

Galapagos' first additional Crohn's disease Phase-2 study is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the investigational selective JAK1 inhibitor filgotinib in adult patients with small bowel Crohn's disease. The Company stated that approximately 100 patients in North America and Europe are planned to be randomized in the study to receive one of two doses of filgotinib or placebo, administered for 24 weeks. The primary objective of the study would be to compare filgotinib to placebo in establishing clinical remission, defined as CDAI<150, in patients with small bowel Crohn's disease at week 24.

Galapagos' second Phase-2 study is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with perianal fistulizing Crohn's disease. The Company noted that approximately 75 patients are planned to be randomized in the study to receive one of two doses of filgotinib or placebo administered for 24 weeks. The primary objective is to evaluate the efficacy of filgotinib, compared to placebo, in establishing a combined fistula response at week 24.

These new Phase- 2 studies with filgotinib follow the initiation of the DIVERSITY Phase-3 study in Crohn's disease. Gilead further initiated the FINCH Phase-3 program in rheumatoid arthritis and the SELECTION Phase-2b/3 study in ulcerative colitis in 2016. Filgotinib is an investigational drug and its efficacy and safety have not been established.

What is Perianal Fistulizing Crohn's disease?

Fistulae are inflammatory tracts that most often occur between the distal colon and the perianal region. Fistulae are one of the most severe sequelae of luminal CD and the lifetime risk of occurrence is close to 50% of those with active CD. Fistulizing CD may also cause painful abscesses in the abdomen. In acute fistulizing perianal CD, the lesions represent manifestations of severe disease activity and are concomitantly managed with medications that treat underlying luminal disease (e.g., anti-TNF antibodies). Fistulae may progress to destruction of the sphincter apparatus necessitating proctectomy after years of continual inflammation and tissue erosion.

About Small Bowel Crohn's disease (SBCD)

Crohn's disease causes chronic inflammation and erosion of the intestines and can affect different regions of GI tract including the stomach and small and large intestines. While isolated SBCD is an uncommon presentation of CD, involvement of some portion of the small bowel (SB), particularly the ileum, is common. Patients with SBCD experience cramps, diarrhea, abdominal discomfort (sometimes severe) and fistulae. While there is no therapy approved for SBCD specifically, current treatment involves anti-tumor necrosis factor antibodies and other biologics.

Progress in Cystic Fibrosis Study

On February 23, 2017, Galapagos announced dosing of the first healthy volunteer with a combination of novel corrector GLPG2222 and novel potentiator GLPG2451 for cystic fibrosis in a Phase-1 study. After completion of the dosing of GLPG2451 as a monotherapy, in the new cohorts the safety, tolerability and PK of 14 days co-administration of GLPG2451 and GLPG2222 is being evaluated. The randomized, double-blind, placebo controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium.

Stock Performance

On Friday, March 10, 2017, following the announcement, the stock closed the trading session at $77.78, rising 3.91% from its previous closing price of $74.85. A total volume of 86.47 thousand shares have exchanged hands, which was higher than the 3-month average volume of 74.96 thousand shares. Galapagos' stock price advanced 33.55% in the last three months, 38.57% in the past six months, and 73.46% in the previous twelve months. Shares of the company have a PE ratio of 62.47 and have a market cap of $3.59 billion as per its last closing price.

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SOURCE: Active Wall Street