POS0688 Phase 2a study in patients with moderate-to-severe rheumatoid arthritis and inadequate response to MTX and/or anti-TNFA therapeutics shows that oral ABX464 50 mg once daily is safe, well tolerated and shows promising efficacy results

Daien, Claire;Krogulec, Marek;Gineste, Paul;Steens, Jean-Marc;Durez, Patrick;et.al.
(2022) EULAR 2022 European Congress of Rheumatology — Location: (Denmark) Copenhagen (1.June.2022)

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Authors
  • Daien, Claire
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  • Krogulec, Marek
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  • Gineste, Paul
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  • Steens, Jean-Marc
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  • Durez, PatrickUCLouvain
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Abstract
(en) BACKGROUND: ABX464 upregulates the expression of the anti-inflammatory microRNA miR-124 and is a first-in-class drug candidate as an oral treatment for moderate-to-severe Rheumatoid Arthritis (RA). OBJECTIVES: This phase 2a randomized, double blind, placebo controlled, parallel group 12-week study evaluated the safety and preliminary efficacy of ABX464 (50 and 100 mg q.d.), in combination with methotrexate (MTX) in 60 patients (1:1:1 ratio) with moderate-to-severe active RA who have inadequate response to MTX or/and to an anti-TNFα therapy. Patients who completed the 12-week induction phase could roll over into a 52-week open-label maintenance study to evaluate the long-term safety and efficacy of 50 mg q.d oral ABX464 in RA. METHODS: The primary end point was the safety of ABX464; efficacy endpoints included the proportion of patients achieving ACR20/50/70 responses, disease activity scores (DAS28, SDAI, CDAI), EULAR response, DAS28 low disease activity (DAS28-CRP ≤ 3.2) or remission. Blood samples from patients were used to measure the expression of miR-124 and the relative concentrations of cytokines (baseline and week 8). […]
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Daien, C., Krogulec, M., Gineste, P., Steens, J.-M., Desroys du Roure, L., Biguenet, S., Scherrer, D., Santo, J., Ehrlich, H., & Durez, P. (2022). POS0688 Phase 2a study in patients with moderate-to-severe rheumatoid arthritis and inadequate response to MTX and/or anti-TNFA therapeutics shows that oral ABX464 50 mg once daily is safe, well tolerated and shows promising efficacy results. Annals of the rheumatic diseases, 81(Suppl 1), 623. https://doi.org/10.1136/annrheumdis-2022-eular.2286 (Original work published 2022)