Anokion Reports Positive Results from Phase 2 Trial of KAN-101 for Celiac Disease

CAMBRIDGE, Mass. & LAUSANNE, Switzerland—Anokion SA, a clinical-stage biotechnology firm, recently disclosed promising results from its Phase 2 ACeD-it trial for its primary candidate, KAN-101, targeting celiac disease. The trial findings offer a groundbreaking clinical proof of concept for KAN-101, showcasing its potential as a treatment that could modify the progression of celiac disease. This therapy works by inducing antigen-specific immune tolerance, which it achieves by rebalancing the immune system. The process involves the elimination of harmful T cells, rendering them inactive, and enhancing the responses of regulatory T cells. This approach supports the broader application potential of Anokion’s platform across various autoimmune and immune-mediated diseases.

The Phase 2 segment of the ACeD-it trial employed a double-blind, placebo-controlled methodology to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of KAN-101 in individuals with celiac disease. Participants underwent a gluten challenge after receiving either the KAN-101 treatment or a placebo. Preliminary findings indicated that KAN-101 led to clinically significant reductions in multiple individual symptoms and celiac-specific patient-reported outcome measures following gluten exposure, regardless of the dose level. Additionally, KAN-101 was found to be safe and well-tolerated across all doses tested.

Dr. Deborah Geraghty, CEO of Anokion, emphasized the importance of these findings, noting that they mark a significant therapeutic milestone for those with celiac disease, who currently lack disease-modifying treatment options. She highlighted that KAN-101 is unique in its ability to demonstrate substantial effects across various symptoms following gluten challenges. According to Geraghty, symptomatic relief is crucial for enhancing the quality of life and enabling daily activities for those living with celiac disease. KAN-101 aims to establish durable immune tolerance to gluten, potentially offering long-term benefits. Anokion plans to advance KAN-101 to further development stages and anticipates sharing comprehensive data at future scientific forums.

Knut Lundin, M.D., Ph.D., a professor of medicine at Oslo University Hospital, remarked on the significance of these findings for celiac disease—a chronic autoimmune disorder that can cause severe symptoms and long-term intestinal damage. Lundin noted that by promoting immune tolerance, KAN-101 could provide a long-lasting treatment option for patients who continue to experience symptoms despite adhering to a gluten-free diet. He expressed optimism about the clinical results and looks forward to Anokion’s continued progress with this innovative therapy.

KAN-101 represents a novel approach to immune tolerance therapy. It incorporates a known gluten antigen delivered to the liver and immune system using Anokion’s proprietary liver-targeting technology. To bolster the development of KAN-101, Anokion has partnered with Pfizer Ignite, a collaboration that grants the company access to Pfizer’s extensive resources and expertise, facilitating the rapid development of promising new medicines.

In recognition of its potential, KAN-101 received Fast Track Designation from the FDA in May 2023.

Anokion SA, based in Switzerland, is focused on transforming the management of autoimmune diseases by restoring normal immune tolerance. The company targets a variety of autoimmune conditions, such as celiac disease, multiple sclerosis, and type 1 diabetes. Anokion’s innovative approach employs its immune-based platform to engage natural liver pathways, aiming to restore immune balance and address the root causes of autoimmune diseases.