One year of treatment with daily 50 mg capsules of ABX464 led to the clinical remission of 75% of the patients who had moderate to severe active UC and were enrolled in the company-sponsored open-label trial.
The study’s latest results were shared in a late-breaking session of the United European Gastroenterology Week, held recently in Barcelona, Spain.
The one-year open-label maintenance study included patients who rolled over from a Phase 2a clinical trial (NCT03093259) that consisted of an induction study in which participants were randomly assigned either 50 mg of ABX464 or a placebo, once a day, for two months (eight weeks).
A total of 29 patients completed the induction study, and 35% of those given ABX464 were in clinical remission at the end of the study.
After the initial trial, all participants could continue in an open-label extension study, called ABX464-102 (NCT03368118), in which all patients were given ABX464 for 12 months.
A total of 19 patients completed the maintenance treatment of 50 mg daily capsules of ABX464, which showed “good long-term safety and tolerability.”
During treatment, the mean Mayo Score (tool for assessing disease activity in UC) improved from 8.7 to 1.9 (78% improvement), with scores related to endoscopy findings improving by 89% and values for fecal calprotectin (a biomarker in intestinal inflammation) normalized to a level of 27.9 microg/g.
An endoscopy was performed in 16 of the patients to assess clinical remission — when UC symptoms had resolved. Endoscopy findings are an outcome measure for UC considered critical by regulatory authorities.
At 12 months of treatment, all 16 patients undergoing examinations had an endoscopic score of 0 or 1, which is indicative of healing, and 12 (75%) achieved clinical remission.
Of the 12 patients not in clinical remission at the end of the induction study, seven (58%) achieved clinical remission at the end of the maintenance study, while four failed to reach remission, and one had no endoscopy available.
Three patients without endoscopy at the end of the maintenance study all had normal fecal calprotectin levels, indicating the healing of intestinal inflammation.
“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,” Jean-Marc Steens, M.D., Abivax’s chief medical officer said in a news release.
ABX464 is an investigational, first-in-class small molecule with a novel mechanism of action. It works by promoting the production of a small microRNA (miRNA-124), a mode of action considered safe with profound anti-inflammatory effects in preclinical studies and able to treat UC lesions in the completed Phase 2a trial, Abivax reports.
“Only two-thirds of patients respond to currently available treatments, including biologics, and half of the responders stop responding after six to 12 months, so there is a large unmet need for effective ulcerative colitis therapies,” said William Sandborn, MD, director of the IBD center at University of California San Diego Health, and chief of gastroenterology at UC San Diego School of Medicine.
“The innovative mechanism of action of ABX464 and data from this trial represent a promising new potential approach to the treatment of ulcerative colitis that could provide these patients with an easily administered, once-daily oral, long-term therapeutic management option,” he added.
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