Anokion Announces New Clinical Data from the Phase 1b/2 ACeD-it Trial Supporting KAN-101 as a Potential Disease-Modifying Treatment for Celiac Disease

Two Global Phase 2 Clinical Trials, the Phase 2 portion of ACeD-it and Phase 2a SynCeD Studies, are Ongoing in Individuals with Celiac Disease

New Data Presented During Digestive Disease Week® 2024 Continue to Demonstrate the Safety and Efficacy of KAN-101 as a Potential Treatment for Patients with Celiac Disease

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 additional favorable safety and efficacy data from the company’s ongoing Phase 1b/2 clinical trial (ACeD-it) evaluating KAN-101 as a treatment for celiac disease. The findings were presented on Sunday, May 19, 2024 in an oral 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,” at Digestive Disease Week (DDW) 2024.

Anokion’s Phase 1b/2 ACeD-it (assessment of KAN-101 in Celiac Disease) trial is expecting to enroll up to 120 patients. The Phase 1b portion is an open-label trial with multi-ascending dose (MAD) cohorts and the Phase 2 portion is a double-blind, placebo-controlled, parallel design trial. KAN-101 was granted Fast Track Designation in May 2023.

“We are happy to report that the data update from the Phase 1b portion of our Phase 1b/2 ACeD-it trial further validate our findings from the Phase 1 trial and continue to differentiate KAN-101's unique liver-targeting mechanism and its potential to induce immune tolerance to gluten in individuals with celiac disease,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion. “We remain excited by KAN-101's ability to reduce the broader inflammatory mechanisms triggered by gluten exposure and its potential to offer durable treatment options to patients where there is currently no disease-modifying therapy available. Based on these positive results, we continue to advance KAN-101 for the treatment of Celiac Disease in the clinic and are actively enrolling patients into two ongoing global Phase 2 clinical trials. We appreciate the participation of the celiac disease patient and physician communities and look forward to providing further updates later this year.”

Consistent with results from the Phase 1 ACeD trial of KAN-101 in individuals with Celiac Disease, data presented from the Phase 1b portion of the ACeD-it trial demonstrate that KAN-101 was safe and remained well-tolerated at higher dose levels up to 3mg/kg. The induction of functional tolerance following gluten challenge was also observed. The Phase 1b portion of the trial was an open-label 3+3 MAD design with three administrations of KAN-101 via IV infusion administered on Days 1, 4 and 7. Findings from this analysis showed that:

• KAN-101 was rapidly cleared from circulation and exhibited a target-mediated clearance profile, consistent with the platform liver-targeting mechanism
• KAN-101 continued to exhibit modulation of GC-induced cytokine response at the higher dose levels
• The observed modulation of T cell, innate and endothelial cytokines indicates regulation of a broader immune response to gluten

Based on the data from the Phase 1 ACeD and Phase 1b portion of the ACeD-it clinical trials, the Company continues to evaluate the efficacy of KAN-101 in multiple global Phase 2 studies. The Company is actively enrolling patients into its Phase 2 portion of the Phase 1/b ACeD-it trial and its Phase 2a SynCeD trial in individuals with Celiac Disease. The Company plans to provide an update from both global studies later in 2024.

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.