AbbVie's rheumatoid arthritis candidate ABT-494 successful in two mid-stage studies
Sep 25 2015, 08:27 ET | About: AbbVie Inc. (ABBV) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
AbbVie's (NYSE:ABBV) product candidate for the treatment of rheumatoid arthritis (RA), the selective JAK1 inhibitor ABT-494, successfully achieved its primary endpoint in two Phase 2 studies.The first, BALANCE-1, assessed the safety and efficacy of four doses of ABT-494 in 276 patients with moderate-to-severely active RA who had an inadequate response or intolerance to anti-TNF biologic therapy. The primary endpoint was the percentage of subjects achieving ACR20 (20% improvement) at week 12. All four dose level arms (3 mg, 6 mg, 12 mg, 18 mg: all twice-daily) met the endpoint.The second, BALANCE-2, assessed five doses of ABT-494 in 300 patients with the same RA profile as BALANCE-1 but who had an inadequate response to methotrexate. The primary endpoint was the same. Four of the five dosage arms met the endpoint (6 mg, 12 mg, 18 mg, 24 mg: all twice-daily), but the 3 mg twice-daily arm did not.The most common adverse event was headache (<5%).The company intends to advance a once-daily formulation of ABT-494 to Phase 3 development by year end.