57% of the patients (13/23) were in remission at week 52, assessed by the DAS28-CRP (< 2.6), corresponding to 33% (13/40) using the full analysis set (FAS).
All 23 patients (100%) who completed 52 weeks of treatment achieved at least an ACR20 response, which translates into 58% (23/40) in the FAS.
It is remarkable, that according to the observed cases population, 83% (19/23) and 52% (12/23) achieved even an ACR50 and ACR70 response respectively, corresponding to 48% (19/40) and 30% (12/40) according to the FAS.
17 patients discontinued the study during the first year of maintenance treatment due to either mild to moderate adverse events or worsening RA.
ABX464 was safe and the nature of the adverse events is consistent with what has been observed in more than 1,000 subjects who have so far been treated in other clinical trials with ABX464 across different indications. At present, some UC patients have been continuously treated for four years.
ABX464 phase 2a induction and maintenance studies in rheumatoid arthritis
The placebo-controlled clinical phase 2a study was designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered once daily (50mg or 100mg), in combination with methotrexate (MTX). 60 patients who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNFα) biological therapeutics participated in this randomized and double-blind trial. The study was conducted in 21 study centers across four European countries (France, Belgium, Poland and Hungary).
After the end of the 12-week induction study, 40 patients continued their treatment in the maintenance study with a once-daily oral dosing of 50mg ABX464.
In June 2021, Abivax communicated the 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. 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.
Epidemiology and market size in rheumatoid arthritis
In 2021, there were an estimated 3.8M diagnosed cases of rheumatoid arthritis in G7 countries (US, France, Germany, Italy, Spain, UK and Japan). The total market size in RA is currently USD 22.3B annually, based on 2021 pharmaceutical sales estimates for rheumatoid arthritis in these countries.
The currently accessible market for ABX464 in IBD (ulcerative colitis and Crohn’s disease) and RA is estimated to grow to USD 50B by 2026.(3)
About Abivax (www.abivax.com)
Abivax, a clinical stage biotechnology company, is developing novel therapies that modulate the physiological inflammation and immunological pathways to treat patients with chronic inflammatory diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe chronic inflammatory diseases, and ABX196 to treat hepatocellular carcinoma. More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.
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This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the
Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document d’Enregistrement Universel). Special consideration should be given to the potential hurtles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and ethics committees of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC, clinical data, Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law.
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(1) The American College of Rheumatology ACR score measures the efficacy of treatments for rheumatoid arthritis patients. The ACR20/50/70 measures a 20/50/70% improvement in the tenderness and swelling in designated joints and a 20/50/70% improvement in at least 3 of the 5 following measures: investigator’s and patient’s reported global assessment of disease scales, patient’s reported pain scale, CRP level, healthy assessment questionnaire.
(2) DAS28-CRP-Disease Activity Score for 28 joints - C reactive Protein
(3) Source: Informa