Galapagos’ closely watched rheumatoid arthritis drug filgotinib scores in PhIIb

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Belgium’s Galapagos (Euronext: GLPG) says that its oral JAK1 inhibitor filgotinib met its primary and other endpoints in a crucial Phase IIb study for rheumatoid arthritis. Analysts have been keeping a particularly close eye on this data drop since Bloomberg flagged Galapagos a few weeks ago as a potential takeover target if the data for this would-be biologics successor were good.

In these days of M&A frenzy in biopharma, it doesn’t take much to stoke buzz about possible buyouts–or fire them back up.

Today’s fresh tinder: The drug–aka GLPG0634–registered improvements in ACR20 scores, with up to 80% of the people in various dosing groups seeing a 20% improvement in disease symptoms over 12 weeks of add-on therapy to methotrexate. The primary endpoint was an improvement in ACR20 scores for a daily dose of 200 mg compared to a placebo. A total of 594 patients who had inadequate response to methotrexate were recruited for the study.

Galapagos added that statistically significant ACR50 scores were also achieved with all dose levels and dose regimens, seeing a significant improvement after one week, indicating rapid efficacy for some patients.

Good news for Galapagos is also good news at AbbVie ($ABBV), which partnered on the drug. Filgotinib is also in the clinic for Crohn’s disease and has applications in other inflammatory conditions. Prespinout, AbbVie agreed to a $1.35 billion deal on this drug back in 2012: $150 million upfront, a $250 million payment for a successful midstage program and $1 billion more in promised milestones.

As Bloomberg noted, AbbVie and Johnson & Johnson ($JNJ) are both losing blockbuster arthritis franchises, and they both have a stake in Galapagos. J&J owns a piece of the company. And Bryan Garnier & Co. is stoking the speculation with an estimate that the new orals coming through the pipeline could be worth up to $27 billion. But Galapagos and AbbVie aren’t alone in this field, or ahead. Eli Lilly ($LLY) and Incyte ($INCY) have been racking up equally positive Phase III data for the oral baricitinib, which is likely to heighten the significance of the safety data for these therapies.

“The last decade saw an important progress in RA treatment with biologicals,” said René Westhovens from the University of Leuven, a principal investigator for DARWIN 1. “The current data with this oral drug spell hope for a potential future treatment option that combines fast onset of action and ease of administration. I am particularly impressed by the rapid improvement reported by the patients. Also the increase in hemoglobin is important for my patients, as this may lessen fatigue and enhance their overall well-being.”

“Based on these 12-week results in RA, we believe that filgotinib has a promising future to address a significant medical need. We look forward to seeing the DARWIN 2 monotherapy results in just a few weeks,” said Dr. Piet Wigerinck, chief scientific officer of Galapagos.

http://www.fiercebiotech.com/story/galapagos-closely-watched-rheumatoid-arthritis-drug-filgotinib-scores-phiib/2015-04-14

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