Anokion Reveals New Phase 1b/2 Data on KAN-101 for Celiac Disease

Anokion SA, a biotechnology company based in Cambridge, Massachusetts, and Lausanne, Switzerland, has announced promising new safety and efficacy data from its ongoing Phase 1b/2 clinical trial (ACeD-it) investigating KAN-101 as a treatment for celiac disease. The findings were disclosed during an oral presentation at the Digestive Disease Week 2024 conference, held on May 19, 2024. The presentation, titled "Assessment of KAN-101 in CeD and Immune Tolerance (ACeD-it) Study, Ph1b Data with Higher Dose Levels of KAN-101, a Novel Immune Tolerance Therapy for Celiac Disease,” underscored the potential of KAN-101 to induce immune tolerance to gluten, a critical challenge for individuals with celiac disease.

The Phase 1b/2 ACeD-it trial is designed to enroll up to 120 patients, divided into two phases. The Phase 1b portion is an open-label trial featuring multiple ascending dose (MAD) cohorts, while the Phase 2 portion adopts a double-blind, placebo-controlled, parallel design. In May 2023, KAN-101 received Fast Track Designation, emphasizing its significance in addressing an unmet medical need.

According to Deborah Geraghty, Ph.D., the CEO of Anokion, the latest data from the Phase 1b segment reinforces findings from the earlier Phase 1 trial. The results highlight KAN-101's unique liver-targeting mechanism, which has shown the potential to induce immune tolerance to gluten in celiac disease patients. Geraghty expressed optimism about KAN-101's ability to mitigate broader inflammatory responses triggered by gluten exposure and its potential to offer a durable treatment option where no disease-modifying therapies currently exist. Building on these positive outcomes, Anokion is moving forward with KAN-101 for celiac disease treatment and is actively enrolling patients in two ongoing global Phase 2 clinical trials.

The data from the Phase 1b portion of the ACeD-it trial demonstrated that KAN-101 is safe and well-tolerated even at higher doses up to 3mg/kg. The trial used an open-label 3+3 MAD design, with three administrations of KAN-101 via intravenous infusion on Days 1, 4, and 7. Key findings included:

1. Rapid clearance of KAN-101 from the bloodstream and a target-mediated clearance profile consistent with the liver-targeting mechanism.
2. Continued modulation of gluten-induced cytokine response at higher dose levels.
3. Indications of a broader immune response regulation to gluten through the modulation of T cell, innate, and endothelial cytokines.

The encouraging data from both the Phase 1 ACeD trial and the Phase 1b portion of the ACeD-it trial have led Anokion to continue evaluating KAN-101's efficacy through multiple global Phase 2 studies. The company is actively enrolling patients in the Phase 2 portion of the ACeD-it trial and the Phase 2a SynCeD trial. Anokion plans to provide updates on these studies later in 2024.

Anokion SA is a clinical-stage Swiss biotechnology company that aims to significantly impact the lives of patients with autoimmune diseases by restoring normal immune tolerance. The company's focus extends to both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion's innovative approach leverages its immune-based platform, targeting natural pathways in the liver to restore immune tolerance and address the root causes of autoimmune diseases.