ABX464 Effective at Keeping UC Patients in Remission Over Time, Data Show

ABX464 Effective at Keeping UC Patients in Remission Over Time, Data Show
ABX464, Abivax’s treatment candidate for ulcerative colitis (UC), continues to be safe and effective over time at keeping patients with moderate-to-severe UC in clinical remission, according to two-year data from a Phase 2a trial and its extension study. “We are very excited about the two-year open label Phase 2a maintenance results, which provide further momentum for our clinical development efforts with ABX464 to address the high unmet medical need in UC,” Hartmut J. Ehrlich, MD, CEO of Abivax, said in a press release. “These recent findings reinforce the potential of ABX464 as a well-tolerated and efficacious once-daily oral therapy for patients with moderate-to-severe ulcerative colitis,” he added. ABX464 is an oral small molecule designed to promote the production of a microRNA, called miRNA-124, that has strong anti-inflammatory properties. MicroRNAs are tiny RNA molecules that control the expression, or activity, of several genes; RNA molecules are the templates that cells use to produce proteins. The safety and efficacy of ABX464 were investigated in the Phase 2a ABX464-101 trial (NCT03093259) and its open-label extension study, called ABX464-102 (NCT03368118). The original trial enrolled a total of 32 adults with moderate-to-severe UC, who were intolerant or failed to respond to treatment with immunomodulators, TNF inhibitors, Entyvio (vedolizumab), and/or corticosteroids. In the Phase 2a trial, participants were randomly assigned to receive an oral capsule containing 50 mg of ABX464, or a placebo, once a day, for eight weeks. After completing this trial, patients were given the option to continue treatment with ABX464 in the open-label extension study. From the initial 32 patients, 22 entered in the trial’s open-label extensio
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