Abivax Bolstered by Positive Mid-Stage Results from Ulcerative Colitis Treatment

Shares of Paris-based Abivax have shot up more than 8 percent this morning after the company posted positive mid-stage results for its ulcerative colitis treatment, ABX464.

This morning the company released topline results from its Phase IIa trial showing treatment with the experimental drug resulted in “statistically significant efficacy based on both clinical and endoscopic endpoints in this study.” Abivax’s ABX464 has a mechanism of action that is triggered by an increased expression of miR124, a potent anti-inflammatory microRNA, the company said.

Final eight-week topline data from the Phase IIa study showed 35 percent of patients on the Abivax treatment saw clinical remission, compared to 11 percent of placebo patients. When it came to mucosal healing, 50 percent of ABX464 patients saw a positive response, compared to 11 percent of patients on placebo. Abivax’s ABX464 yielded an overall 70 percent clinical response rate, compared to 30 percent for placebo, results show.

Additionally, the company noted that calprotectin, the best-studied biomarker in ulcerative colitis, was markedly reduced in patients who received ABX464 in comparison to placebo after four weeks of treatment.

For ulcerative colitis patients treated with ABX464 the onset of therapeutic effect was rapid, the company said. Efficacy could be observed following two weeks of treatment and the results “became significant” at eight weeks.

Ulcerative colitis is a debilitating inflammatory bowel disease in adults and children, with limited therapeutic management options for many patients. It is estimated that close to 1 million patients with ulcerative colitis live in the United States.

Jean-Marc Steens, chief medical officer of Abivax, said the results of the Phase IIa trial have exceeded the company’s expectations given the “statistically significant, strong efficacy” that was already observed in the study.

“They validate our hypothesis that ABX464 novel mechanism of action would result in potent anti-inflammatory properties in patients. Like other chronic inflammatory diseases, ulcerative colitis is a debilitating disease that greatly affects patients’ quality of life and warrants expensive innovative therapies. We look forward to developing and potentially market ABX464 as a well-tolerated oral treatment for this large patient population,” Steens said in a statement.

No severe adverse events attributed to ABX464 were reported in the trial. Full clinical trial data will be presented at upcoming international scientific conferences, the company said.

Hartmut Ehrlich, chief executive officer at Abivax, called the Phase II a data impressive. He said it indicates the potential for ABX464 to bring relief to UC patients who “are not adequately helped by currently available therapeutics and are struggling from the devastating consequences of this inflammatory disease.” Based on the results, Abivax will initiate a Phase IIb dose-ranging study for ABX464. Ehrlich added that the data is also leading the company to pursue mid-stage trials in other inflammatory indications, such as Crohn’s disease.