ABX464 for Rheumatoid Arthritis
ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in a completed Phase 2a induction study as well as a 12-month maintenance study 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 ongoing Phase 2a clinical trial in rheumatoid arthritis (RA).
In the Clinic
The Phase 2a study, ABX464-301, investigates the safety and tolerability of ABX464 in combination with methotrexate in patients with moderate-to-severe active RA. Patients enrolled in the study had an inadequate response to methotrexate or/and to one or more anti-tumor necrosis factor alpha (TNFα) therapies.
Patients who complete the ABX464-301 trial, have the possibility to roll over into a Phase 2a open-label study, ABX464-302, aiming at the evaluation of the one-year safety and efficacy of ABX464 as maintenance therapy in RA.