Anokion Announces Positive Symptom Data from its Phase 2 Trial Evaluating KAN-101 for the Treatment of Celiac Disease

The data indicate KAN-101 reduces multiple gluten induced symptoms and celiac-specific composite measures in a Phase 2 trial

KAN-101 was safe and tolerated in individuals with celiac disease

Celiac disease is a serious autoimmune disease that currently has no approved therapeutic treatments

CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced positive symptom data from its Phase 2 ACeD-it trial evaluating its lead candidate, KAN-101, in individuals with celiac disease. The study data serves as the first symptomatic clinical proof of concept for KAN-101 and its potential as a disease-modifying treatment for celiac disease. KAN-101 induces antigen-specific immune tolerance by rebalancing the immune system through removal of pathogenic T cells, rendering pathogenic T cells non-responsive, and expanding regulatory T cell responses, supporting the potential application of the Anokion platform in a broad range of autoimmune and immune-mediated diseases.

The Phase 2 portion of the ACeD-it trial is a double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of KAN-101 in individuals with celiac disease. Pharmacodynamic and prespecified exploratory endpoints were assessed using a gluten challenge after patients received treatment with KAN-101 or placebo. Preliminary analysis showed that KAN-101 demonstrated clinically meaningful reductions across multiple individual symptoms and celiac-specific patient reported outcome composite measures following gluten exposure at all dose levels. KAN-101 was safe and tolerated at all dose levels investigated.

“The positive symptom data from the Phase 2 ACeD-it study represents a transformational new therapeutic milestone for individuals with celiac disease, who today have no disease-modifying treatment options available. To date, KAN-101 is the only product candidate to demonstrate clinically meaningful effects across multiple symptoms following gluten challenge,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion. “Symptomatic relief and control are important to quality of life and resumption of activities of daily living for individuals with celiac disease and KAN-101 has been developed to establish durable immune tolerance to gluten, potentially offering long-term therapeutic benefit to people living with celiac disease. We look forward to advancing KAN-101 to the next stage of development and sharing full data and analysis at a future scientific conference or publication.”

“Celiac disease is a chronic autoimmune disorder that can result in severe, life-altering symptoms and long-term gut damage,” said Knut Lundin, M.D, PhD, professor of medicine and consultant, at Oslo University Hospital. “By inducing immune tolerance, KAN-101 has the potential to offer a durable, disease-modifying treatment option for patients continuing to experience symptoms despite being on a gluten-free diet. Clinically meaningful reduction of multiple symptoms in response to gluten exposure remains elusive and I am highly encouraged by these data and look forward to Anokion’s continued advancement with this novel agent.”

KAN-101 is a novel immune tolerance therapy, which encompasses an established gluten antigen delivered to the liver and immune system using the company’s proprietary liver-targeting technology. To support the development of KAN-101, Anokion previously entered into an agreement with Pfizer Ignite, which offers biotech companies access to Pfizer’s significant resources, scale, and expertise to accelerate the progression of potential new breakthrough medicines for patients.

KAN-101 was granted Fast Track Designation from the FDA in May 2023.

About Anokion

Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease. For more information, please visit anokion.com.