Galapagos' arthritis drug shines in another PhIIb study as M&A rumors simmer

Galapagos' AbbVie ($ABBV)-partnered rheumatoid arthritis drug hit the mark in another Phase IIb trial, stoking rumors that the Belgian biotech could be in the M&A crosshairs.

The drug, filgotinib, met its main goal of beating out placebo in improving disease symptoms after 12 weeks in a study on RA sufferers who don't respond to the common anti-inflammatory drug methotrexate. In the trial, all three dose levels of the oral treatment significantly outperformed placebo in getting patients to ACR20, an American College of Rheumatology measure meaning at least 80% of subjects charted a 20% or more reduction in symptoms. All three doses also hit statistical significance on ACR50, a secondary goal, but missed on ACR70 at 12 weeks. Each dose also marked a significant improvement in Disease Activity Score, a composite of RA measurements.

Now the 283-patient trial will continue through 24 weeks, Galapagos said, at which point the company will take another look at ACR20, ACR50 and ACR70 results with plans to report back next quarter.

Galapagos Chief Scientific Officer Piet Wigerinck

Filgotinib, a JAK1 inhibitor, came through in a 594-patient Phase IIb study earlier this month, significantly improving RA symptoms when paired with methotrexate. Across both trials, the drug came through on its efficacy goals and demonstrated a fast onset of action, Galapagos Chief Scientific Officer Piet Wigerinck said, building the case for filgotinib as a disruptive force in RA.

"These data support our belief that filgotinib could be used prior to initiating anti-TNF therapy," Wigerinck said in a statement, name-checking a blockbuster class of drugs that includes AbbVie's Humira. "Selective inhibition of JAK1 increases hemoglobin, which is important to improve the patient's fatigue and thereby overall condition."

And that very promise has led to takeout speculation for Galapagos. AbbVie, which signed a $1.4 billion deal to cut in on filgotinib in 2012, may want to buy its partner outright as it prepares to lose patent protection on Humira, analysts have said. And Johnson & Johnson ($JNJ), in a similar position with the TNF-blocking Remicade, may be considering the same.

But Galapagos doesn't seem to be waiting by the phone. The company, already traded on the Euronext exchange, this month unveiled plans to jump onto the NASDAQ with a $150 million IPO. The plan is to raise enough cash to get filgotinib into Phase III and support a pipeline that includes treatments for inflammatory bowel disease, cystic fibrosis and idiopathic pulmonary fibrosis.

- read the results (PDF)

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