ABX464 for Rheumatoid Arthritis
ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in the completed Phase 2a and Phase 2b induction studies as well as in ongoing long-term maintenance studies in patients with moderate-to-severe ulcerative colitis (UC).
In addition to the clinical observations in UC patients, Abivax generated promising pre-clinical data from collagen-induced arthritis animal models that were the basis for moving into the Phase 2a clinical trial in rheumatoid arthritis (RA).
In June 2021, Abivax announced excellent top-line results of the induction phase of its Phase 2a clinical study of ABX464 administered in combination with methotrexate (MTX) for the treatment of active moderate to severe RA. 60 patients who had either an inadequate response to methotrexate and/or TNFα inhibitors participated in the study.
The primary endpoint of this study, safety and tolerability, was met with 50mg ABX464 once daily demonstrating a good safety and tolerability profile in the overall patient population during the 12-week induction phase.
Although the sample size of this study was not powered to show efficacy, the 50mg group already showed statistically significant differences for the key secondary endpoint ACR20 compared to placebo at week 12 in the Per Protocol population.
Patients who completed the induction study could roll over into a two-year open-label maintenance study to evaluate the long-term safety and efficacy of 50mg once daily oral ABX464 in RA.
In the Clinic
Based on the results of the Phase 2a clinical study, Abivax is preparing to start a clinical Phase 2b program in RA in early 2022.