ABIVAX Reports Impressive 12-month Efficacy and Safety Data from ABX464 Ulcerative Colitis Maintenance Study at United European Gastroenterology Conference
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ABIVAX SA (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced today new data showing that 75% of the patients were in clinical remission after a 12-month open-label oral ABX464 Phase 2a maintenance study in subjects with moderate-to-severe active ulcerative colitis (UC) who had failed immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids.
The oral presentation of the data by Prof. Dr. Severine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium is taking place today at the United European Gastroenterology (UEG) Week in Barcelona, Spain during the late breaking abstracts session “IBD Highlights”.
Dr Jean-Marc Steens, M.D., Chief Medical Officer of Abivax, said: “Our new data, presented as late breaker during the “IBD highlights session“ at UEG, exceeded our expectations regarding safety and efficacy during the 12-month maintenance study. Compared to our excellent 2-month induction study data, we observed further improvements of clinical remission rates, confirmed by endoscopy, and a decrease of fecal calprotectin to normal levels. These findings confirm the potential of oral ABX464 as a well-tolerated and efficacious once-daily oral therapy for UC patients. This drug candidate has the potential to significantly improve the quality of life of patients who currently have limited treatment options in UC and other inflammatory indications, including Crohn’s disease and rheumatoid arthritis.”
The one year open-label ABX464 maintenance study was conducted in 22 patients without treatment interruption after completion of the randomised, double-blind, placebo-controlled 8 weeks induction study. A total of 19 patients completed the one year ABX464 open label maintenance study and showed good long-term safety and tolerability of 50mg given orally over 52 weeks.
At month 12, an endoscopy to assess clinical remission status (the critical parameter for regulatory authorities) was performed in 16/19 patients. During treatment with ABX464, patients reduced their total Mayo Score (mean) from 8.7 to 1.9 (-78%), their endoscopic subscore from 2.3 to 0.25 (-89%) and the fecal calprotectin biomarker (median) from 1044 microg/g to 27.9 microg/g (-97%).