AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced results from two Phase 2 clinical trials evaluating its investigational selective JAK1 inhibitor, ABT-494, in patients with inadequate response to either methotrexate or TNF inhibitors. The clinical trials, BALANCE-I and BALANCE-II, achieved ACR20 at week 12 across all dose levels, except the lowest dose in BALANCE-II. BALANCE-I and BALANCE-II evaluated patients with moderate to severe rheumatoid arthritis with inadequate responses to prior anti-TNF (TNF-IR) or methotrexate (MTX-IR) treatment, respectively.
"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, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "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."
Overall rates of discontinuation and serious adverse events were <5% and <3%, respectively, across both studies. Serious infections were reported in two patients, one on placebo and one on ABT-494. The most common adverse event was headache, which occurred in less than 5% of ABT-494 treated patients.
"These were well-designed studies across a broad dose range that allow us to understand the full potential of inhibiting this pathway," said Mark Genovese, M.D., professor of medicine, Stanford University Medical Center, Division of Immunology and Rheumatology. "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 TNF-IR 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."
BALANCE-I enrolled 276 patients, approximately 30 percent of whom had an inadequate response to two or more anti-TNF agents and 20 percent had an inadequate response to treatment with a non-TNF biologic. BALANCE-II enrolled 300 patients with an inadequate response to prior treatment with methotrexate.
"The levels of ACR response across the ABT-494 studies are impressive and warrant further investigation, particularly in treatment-refractory patients with the highest unmet need," said Joel Kremer, M.D., director of research, The Center for Rheumatology in Albany, New York and a clinical investigator on BALANCE-I.