AbbVie plans to advance ABT-494 to Phase 3 studies in rheumatoid arthritis

And in BALANCE-II, 300 patients who had experienced an inadequate response to methotrexate were given one of five doses of the drug for 12 weeks, and significant differences vs placebo on ACR20 were seen for all but the lowest dose group, the company reported. A total of 35% of patients in the placebo group had ACR20 responses.

If AbbVie’s drug ABT-494 succeeds in late-stage studies and is approved, analysts said that would help spare the suburban Chicago company about $1 billion in royalties it would have had to pay Galapagos for its pill, called filgotinib.

“We believe ABT-494 has the potential to become a best-in-class therapy for patients”, AbbVie Chief Scientific Officer Michael Severino said in a statement, adding, in reference to filgotinib: “In our view, ABT-494 also offers a faster path to Phase III development with less uncertainty”.

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. ( ABBV ) announced that it will advance ABT-494, its internally developed investigational selective JAK1 inhibitor, to Phase 3 studies in rheumatoid arthritis. Less than 3% of patients reported serious adverse events, with the most common complaint being headache. In BALANCE-2, ACR20 response climbed to 82%, with 50% of patients achieving ACR50, AbbVie said.

Protecting its moatAbbVie’s Humira has been the planet’s top-selling drug for years and its best-in-class status is due at least in part to its widespread use in the treatment of rheumatoid arthritis, an autoimmune disease that afflicts 1.3 million Americans. Doses tested included 3, 6, 12, and 18 mg BID. There were two cases of serious infection; however, only one of those two cases occurred in the ABT-494 arm of the study. The primary endpoint was the percentage of subjects achieving ACR20 (20% improvement) at week 12.

“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, MD, of Albany Medical College, who was a clinical investigator for BALANCE-I.