Anokion SA, a clinical-stage biotechnology company, has announced additional favorable safety and efficacy data from its ongoing Phase 1b/2 clinical trial (ACeD-it) evaluating KAN-101 as a treatment for celiac disease. The findings were presented at Digestive Disease Week (DDW) 2024, demonstrating KAN-101's potential as a disease-modifying therapy for patients with celiac disease.
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Trial Overview: The ACeD-it trial is expected to enroll up to 120 patients, with the Phase 1b portion being an open-label trial with multi-ascending dose (MAD) cohorts and the Phase 2 portion a double-blind, placebo-controlled, parallel design trial. KAN-101 was granted Fast Track Designation in May 2023.
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Key Findings: Data from the Phase 1b portion of the trial showed that KAN-101 was safe and well-tolerated at higher dose levels up to 3mg/kg. The trial also observed the induction of functional tolerance following gluten challenge. KAN-101 exhibited a target-mediated clearance profile, consistent with its liver-targeting mechanism, and showed modulation of GC-induced cytokine response at higher dose levels.
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Future Steps: Anokion is actively enrolling patients into two ongoing global Phase 2 clinical trials (the Phase 2 portion of ACeD-it and Phase 2a SynCeD Studies) and plans to provide further updates later in 2024.
Deborah Geraghty, Ph.D., CEO of Anokion, expressed enthusiasm about KAN-101's potential to offer durable treatment options for celiac disease patients, emphasizing the importance of the ongoing clinical trials and the support from the celiac disease patient and physician communities.
Anokion SA is dedicated to developing treatments for autoimmune diseases by restoring normal immune tolerance, leveraging its immune-based platform that targets natural pathways in the liver to address the underlying causes of autoimmune diseases.
