ABX464: A Potential Candidate With a Novel Mechanism of Action for the Treatment of Rheumatoid Arthritis
EULAR 2022: ABX464 for Rheumatoid Arthritis
Phase IIa study in patients with moderate to severe rheumatoid arthritis and inadequate response to MTX and/or anti-TNFα therapeutics shows that oral ABX464 50 mg once daily is safe, well-tolerated, and shows promising efficacy results (Abstract # POS0688).
ABX464 is a first-in-class medication candidate for treating moderate to severe RA by upregulating the expression of the anti-inflammatory microRNA miR-124.
The Phase IIa trial showed promising findings in assessing the safety and preliminary efficacy of ABX464 in combination with methotrexate (MTX) in patients with moderate-to-severe active RA who had an unsatisfactory response to MTX or/and anti-TNF treatment.
The primary outcome was ABX464's safety; efficacy endpoints comprised the proportion of patients who achieved ACR20/50/70 responses and disease activity scores (DAS28, SDAI, CDAI), EULAR response, DAS28 low disease activity or remission, and EULAR response. In the per-protocol population, ABX464 50 mg had significantly larger proportions of patients attaining ACR20 (56%) and ACR50 (31%) responses at Week 12 compared to placebo. The drug ABX464 50 mg was found to be safe and well-tolerated, with only two major adverse events (SAEs) reported (one in the placebo group and one on ABX464 100 mg).
KOL Insights
The high levels of sustained response rates in the Phase IIa maintenance trial with obefazimod in RA patients, along with its unique mode of action and clinical profile, look encouraging, and obefazimod has the potential to play a significant role in the future management of RA patients, according to promising data presented at EULAR.
With 50 mg obefazimod once daily, the Phase II study's primary aim was met, indicating a positive safety and tolerability profile in the whole patient population during the 12-week induction phase.
The efficacy and safety results of ABX464, a first-in-class therapeutic candidate, point to continued research as an oral therapy for RA patients taking 50 mg twice daily or less. In RA, there is a clear need for novel modes of action, and obefazimod may be able to fill that need. If other clinical trials show similar excellent results, this medicine could become a viable treatment option for RA sufferers.
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