Chicago-based biopharmaceutical company AbbVie Inc. will no longer buy rights for Galápagos NV's rheumatoid arthritis drug in Belgium. The American company will pursue the development of its own drug after mid-stage clinical tests yielded positive results.
The patients involved in the study were taking two common rheumatoid arthritis treatments in the past - methotrexate and tumor necrosis factor (TNF) inhibitors.
The first clinical study is called BALANCE-I studied 276 patients who recently took TNF inhibitors but showed scarce response. They were given one of four ABT-494 doses in the span of 12 weeks. The patients showed 20 percent improvement in their symptoms.
The second clinical study called BALANCE-II looked into 300 patients who showed poor response to methotrexate. The patients received one of five doses of ABT-494 for 12 weeks. All dose levels showed improvement except for the lowest dose given. During the two clinical tests, AbbVie revealed that rheumatoid arthritis patients given ABT-494 showed improvement at week 12.
"We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders", said Michael Severino, AbbVie's company Chief Scientific Officer in a statement. "We are encouraged by the results of our Phase 2 studies and we will advance ABT-494 to Phase 3 studies with a once-daily formulation".
When the drug is finally approved by the Food and Drug Administration (FDA), analysts predict that the drug will save AbbVie about $1 billion dollars in royalties if the Galapagos deal pushed through. The small Belgian company said they are already in talks with other potential partners and would launch their pill into the last set of clinical tests. Moving forward, Galapagos said their two-year collaboration with AbbVie for a cystic fibrosis drug is still ongoing. Test results for the hereditary lung disease drug are expected in early 2016.
AbbVie's ABT -494 and Galapagos' pill called filgotinib belong in the same medicine class that blocks an enzyme called JAK1, which causes inflammation. Rheumatoid arthritis is a condition where the body's immune system attacks the body tissues, which then results in the swelling and stiffness of joints, accompanied with pain.
