Topline data for both the ACeD-it Phase 2 and SynCeD Phase 2a trials of KAN-101 for the treatment of celiac disease expected 1H 2025

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 the early completion of patient dosing in the Phase 2 ACeD-it and Phase 2a SynCeD trials of KAN-101, a potential disease-modifying treatment for celiac disease. Topline data from both the Phase 2 ACeD-it and Phase 2a SynCeD clinical trials are expected in the first half of 2025.

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.

"Completing enrollment early, in partnership with Pfizer Ignite, for both the Phase 2 ACeD-it and the Phase 2a SynCeD trials of KAN-101 represents an important clinical milestone as we advance the development of KAN-101 for the treatment of celiac disease," said Deborah Geraghty, Ph.D., chief executive officer of Anokion. "Currently, no approved drug therapy exists for those managing the effects of celiac disease, other than a life-long strict gluten-free diet. However, symptoms and intestinal damage caused by hidden or incidental exposure to gluten can occur even in patients who are following a strict diet. We look forward to providing additional updates early next year as we believe KAN-101 has the potential to make a meaningful impact on the lives of individuals with celiac disease."

"Pfizer Ignite has worked closely with Anokion to accelerate clinical development for KAN-101," said Kathy Fernando, senior vice president and global head of Pfizer Ignite. "We are thrilled this productive collaboration has resulted in the early delivery of critical milestones for the program. This achievement demonstrates the value of the Ignite model and, importantly, may one day lead to a breakthrough for people living with celiac disease."

The Phase 2 portion of the ACeD-it trial is a double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and plasma biomarkers of KAN-101 in individuals with celiac disease.

The Phase 2a SynCeD clinical trial is also a double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of KAN-101, and assess any histological changes induced from gluten exposure in individuals with celiac disease.

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.

Chris Brinzey
ICR Healthcare
Chris.Brinzey@icrhealthcare.com