Abivax SA said its drug ABX464 was shown to be effective in treating a type of inflammatory bowel disease under a midstage study.
Under the phase 2a trial, called ABX464-101, the therapy showed statistically significant efficacy in treating patients with moderate-to-severe ulcerative colitis whose diseases did not respond to anti-tumor necrosis factor monoclonal antibodies or corticosteroids — treatments that alleviate inflammation.
Ulcerative colitis, a chronic and often debilitating disease, causes diarrhea, abdominal pain, cramping and weight loss. ABX464 works by increasing the body's expression of miR124, an anti-inflammatory substance.
ABX464 was better than placebo in colorectal mucosal healing — a measure of disease activity — while achieving its therapeutic effect faster under the 32-patient trial. The therapy also reduced calprotectin, a biomarker in ulcerative colitis, better than placebo after 4 weeks of treatment.
Based on the results of the study, Paris-based Abivax plans to start a phase 2b dose-ranging study in Europe with potential inputs from U.S. key opinion leaders and the U.S. Food and Drug Administration. The company also said the data encourages it to pursue clinical trials in other inflammatory indications, such as Crohn's disease.