ABX464 safe, effective in treating patients with ulcerative colitis
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Abivax announced positive phase 2b clinical induction and results for ABX464 in the treatment of patients with moderate to severe ulcerative colitis, according to a press release.
In a randomized, double-blind, placebo-controlled trial, patients treated with once-daily ABX464 in each dosage group (25 mg, 50 mg and 100 mg) met the primary study endpoint of statistically significant reduction of Modified Mayo Score at 8-weeks. Further, compared with placebo, patients dosed with ABX464 demonstrated endoscopic improvement, clinical remission, clinical response and reduction of fecal calprotectin.
Researchers observed further increased and durable clinical remission and endoscopic improvement in 51 patients treated with ABX464 50 mg after 48 weeks of open-label maintenance.
“The phase 2b results demonstrate the potential of ABX464 to become a gamechanger for the treatment of UC patients in need of new therapeutic management options. Interestingly, the lowest dose of 25mg was effective across the entire study population, including patients’ refractory to biologics and JAK inhibitors, with a safety profile that is very similar to the placebo group,” Hartmut J. Ehrlich, MD, CEO of Abivax, said in the release. “Based on these data, we are now moving forward as quickly as possible with our phase 3 plan in ulcerative colitis as well as phase 2b/3 in Crohn’s disease to bring ABX464 to the many patients suffering from inflammatory bowel disease.”
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