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Weighing In On Galapagos NV (ADR) (GLPG)’s Lead Studies

Galapagos NV (ADR) (NASDAQ:GLPG) just updated the markets as to the status of a couple of its lead development programs, and while the company hasn’t really moved on the update, there’s plenty of potential for volatility going forward as the content of the releases plays out.

Here’s what’s important.

The company is a biotech based in Belgium, but is active (by way of a number of wholly owned subsidiaries) in Belgium, France, Switzerland, the Netherlands, the United Kingdom, Germany, the United States, and Croatia. It’s a mid-sized company, with a market cap of a little over $2.6 billion.

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The drug in focus for the purpose of this discussion is called filgotinib, and it’s currently under investigation for the treatment of rheumatoid arthritis, ulcerative colitis and Crohn’s disease. It’s the latter of these two indications, UC and Crohn’s, that we will be focusing on here.

First, a bit of science. The drug is what’s called a JAK1 inhibitor, and it’s attempting to improve upon currently available treatments that have a similar MOA, but aren’t as selective as filgotinib. Basically, JAK is an enzyme that is responsible for the signal transmission of large numbers of pro-inflammatory cytokines, and this transmission creates the inflammatory root cause of conditions such as those targeted. However, there are some unpleasant side effects that come about as the result of blanket JAK enzyme inhibition.

There are two types (that are important for this discussion, that is), JAK1 and JAK2, and it’s the JAK2 inhibition that is thought to create the side effects. By selectively targeting the JAK1 enzyme, and avoiding JAK2, Galapagos is hoping its candidate can maintain the efficacy of the current treatments, while doing away with their side effects.

So, what’s coming that could move the company?

Well, the big one is the initiation of a trial called DIVERSITY, which is the above mentioned Crohn’s target trial. It’s a phase III, and it’s designed to investigate efficacy and safety of a couple of different doses of the drug, when administered once-daily, compared to placebo in 1,320 patients with moderately-to-severely-active forms of the disease.

Here’s the interesting part: when the first patient is dosed, Galapagos NV (ADR) (NASDAQ:GLPG) will have triggered a $50 million payment from biotech giant Gilead Sciences, Inc. (NASDAQ:GILD). This dosing should occur before the end of the year (the trial just kicked off this month) so when we get an announcement detailing dosing it should be a real upside driver for the company.

The second trial, the UC trial, is not yet started, but is expected to kick off late in this quarter (so before the end of the year). The trial will be run by Gilead, and it’s a phase IIb/III investigating safety and efficacy in the above mentioned UC indication.

Data from both targets has been strong to date, and the mechanism of action is sound and based on available science, so we’re pretty confident that these trials are going to run smoothly for the company. Of course, we’ll likely see a few hiccups, but so long as the numbers that hit the markets reinforce the data already collected, we should see some considerable upside.

As an aside, but a relevant aside, Gilead also kicked off a phase III back in August in a rheumatoid arthritis indication, and data from that one is expected at some point next year.

The key point here is that these are three potential blockbuster indications, and Galapagos has plenty of potential upside on its current market capitalization if even just one of them reaches commercialization. With a partner like Gilead footing the bill for development, and carrying out the trials in some instances, there’s what looks to be a solid foundation for each, and this makes Galapagos NV (ADR) (NASDAQ:GLPG) very much one to keep an eye on as these studies progress, and we move forward into 2017.

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Note: This article is written by Mark Collins and was originally published at Market Exclusive.

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