Anokion Completes Enrollment Early in Phase 2 Trials of KAN-101 for Celiac Disease

CAMBRIDGE, Mass. & LAUSANNE, Switzerland--Anokion SA, a biotechnology firm in the clinical trial phase, has achieved a significant milestone by completing patient dosing ahead of schedule in their Phase 2 ACeD-it and Phase 2a SynCeD trials for KAN-101. This experimental treatment aims to modify celiac disease by restoring normal immune tolerance. The company anticipates the release of initial data from these trials in the first half of 2025.

KAN-101 is a unique immune tolerance therapy. It incorporates a specific gluten antigen delivered directly to the liver and immune system, utilizing Anokion’s specialized liver-targeting technology. To facilitate the development of this therapy, Anokion has collaborated with Pfizer Ignite. This collaboration provides Anokion with access to Pfizer's extensive resources and expertise, potentially speeding up the advancement of KAN-101.

Deborah Geraghty, Ph.D., the CEO of Anokion, highlighted the significance of achieving early enrollment in the trials, emphasizing that it marks a crucial step forward in developing a treatment for celiac disease. Currently, individuals with this condition have no approved drug therapies and must rely on a strict gluten-free diet. Despite adherence, accidental gluten exposure can still cause symptoms and intestinal damage. Geraghty expressed optimism that KAN-101 could significantly improve the quality of life for those affected by celiac disease, with more updates expected early next year.

Kathy Fernando, a senior vice president at Pfizer Ignite, praised the effective collaboration between Anokion and Pfizer, noting that it has fast-tracked the delivery of essential milestones for KAN-101’s development. She underscored the potential of this partnership to eventually offer a breakthrough solution for individuals suffering from celiac disease.

The ACeD-it trial's Phase 2 segment is a double-blind, placebo-controlled study focused on evaluating the safety, tolerability, pharmacodynamics, pharmacokinetics, and plasma biomarkers of KAN-101 in people with celiac disease. Similarly, the Phase 2a SynCeD trial, also double-blind and placebo-controlled, aims to assess the efficacy, safety, and tolerability of KAN-101, along with any histological changes from gluten exposure in participants.

In recognition of its potential, KAN-101 was awarded Fast Track Designation by the FDA in May 2023, a status that could facilitate its expedited development and review.

Anokion SA operates as a Swiss clinical-stage biotechnology company committed to improving patient outcomes in autoimmune diseases by reinstating normal immune tolerance. The company is engaged in addressing both widespread and rare autoimmune conditions, such as celiac disease, multiple sclerosis, and type 1 diabetes. Through their distinct approach, Anokion utilizes an immune-based platform targeting liver pathways to re-establish immune tolerance and tackle the root causes of autoimmune diseases.