Anokion SA, a biotechnology company with bases in Cambridge, Massachusetts, and Lausanne, Switzerland, has shared encouraging results from its ongoing Phase 1b/2 clinical trial, known as ACeD-it, for KAN-101, a novel treatment for celiac disease. The data, presented at the Digestive Disease Week 2024 conference, highlights KAN-101's potential to induce immune tolerance to gluten, addressing a significant challenge for those with celiac disease.
The ACeD-it trial aims to enroll up to 120 patients, divided into two phases: an open-label Phase 1b with multiple ascending dose cohorts and a double-blind, placebo-controlled Phase 2. KAN-101 received Fast Track Designation in May 2023, underlining its importance in meeting an unmet medical need.
Deborah Geraghty, Ph.D., CEO of Anokion, emphasized the significance of the Phase 1b data, which corroborates earlier findings from the Phase 1 trial. The results showcase KAN-101's unique liver-targeting mechanism, capable of inducing immune tolerance to gluten in celiac disease patients. This mechanism not only mitigates inflammatory responses triggered by gluten but also offers a durable treatment option in a field where disease-modifying therapies are currently lacking.
The Phase 1b segment of the trial demonstrated that KAN-101 is safe and well-tolerated at doses up to 3mg/kg. Key findings include:
- Rapid clearance of KAN-101 from the bloodstream and a target-mediated clearance profile consistent with the liver-targeting mechanism.
- Continued modulation of gluten-induced cytokine response at higher dose levels.
- Indications of broader immune response regulation to gluten through the modulation of T cell, innate, and endothelial cytokines.
Encouraged by these results, Anokion is advancing KAN-101 for celiac disease treatment, with ongoing global Phase 2 clinical trials actively enrolling patients. Updates on these studies are anticipated later in 2024.
Anokion SA is dedicated to transforming the lives of patients with autoimmune diseases by restoring normal immune tolerance. Its innovative approach targets natural pathways in the liver to address the root causes of autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes.
