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AbbVie meets endpoint in phase 2 in patients with RA, ends filgotinib partnership with Galápagos

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AbbVie announced it has met the primary endpoint in a phase 2 study of ABT-494 in patients with rheumatoid arthritis, and that it is ending its partnership with Galápagos and its Janus kinase-1 inhibitor, filgotinib, according to two press releases issued by the company.

The phase 2 trial of the Janus kinase-1 (JAK-1) inhibitor ABT-494 in patients with rheumatoid arthritis (RA) who did not adequately respond to methotrexate therapy showed that patients met the American College of Rheumatology (ACR) criteria for a 20% response (ACR20) in between 56% and 73% of patients, depending on the dosing structure, compared to 35% in placebo.

“These were well-designed studies across a broad dose range that allow us to understand the full potential of inhibiting this pathway," Mark Genovese, MD, professor of medicine, Stanford University Medical Center, Division of Immunology and Rheumatology, said in a press release. “The consistency of response and the overall safety profile of ABT-494 in these two patient populations offer the potential for significant benefit and support advancing this compound into phase 3 studies. In particular, the tumor-necrosis alpha inhibitor-incomplete response population is increasing and represents those failing current standard of care. Anything we can do to better help these patients would represent an important advancement to the field.”

Phase 3 studies are expected to explore a once-daily formulation.

In other news, AbbVie also announced it is ending its partnership with Galápagos and its JAK-1 inhibitor, filgotinib, which met its primary endpoints in a phase 2b trial.

“We believe ABT-494 has the potential to become a best-in-class therapy for patients,” Michael Severino, MD, executive vice president, research and development and chief scientific officer at AbbVie, said in a press release. “In our view, ABT-494 also offers a faster path to phase 3 development with less uncertainty.”

Reference : http://www.abbvie.com.