Anokion Announces Publication in The Lancet Gastroenterology & Hepatology Highlighting Safety and Preliminary Effects of KAN-101 in Celiac Disease in its ACeD Phase 1 Clinical Trial

• KAN-101 represents the first agent to modulate the IL-2 biomarker associated with symptomatic responses to gluten exposure in celiac patients
• KAN-101 advancing in a Phase 1b/2 clinical trial in celiac disease and immune tolerance

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 that The Lancet Gastroenterology & Hepatology has published clinical data on KAN-101 from the Phase 1 ACeD (Assessment of KAN-101 in Celiac Disease) Trial, which support the favorable safety of KAN-101 and signals of dose-dependent reactivity to gluten and induction of immune tolerance in patients with celiac disease. 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.

As highlighted in the publication, in a completed randomized, double-blind, placebo-controlled Phase 1 study in 41 patients with confirmed celiac disease, KAN-101 was safe and well-tolerated in patients treated. No adverse events above a grade 2, no serious adverse events, no dose-limiting toxicities, and no maximum tolerated dose were observed. In addition, treatment with KAN-101 followed by a three-day oral gluten challenge resulted in a reduction in immune reactivity to gluten. KAN-101 administration at three dose levels (0.15, 0.3, and 0.6 mg/kg) led to a dose-dependent modulation of gluten induced IL-2, a reduction in gliadin-specific T cells, and a favorable impact on gut homing CD8+ T cells. Consistent with its liver-targeting mechanism, KAN-101 showed rapid systemic clearance in pharmacokinetic analyses of approximately six hours, with no accumulation upon repeat dosing.

“Celiac disease is a serious autoimmune disease triggered by ingestion of gluten for which there are no approved therapeutic treatments available. The preliminary reduction in immune gluten sensitivity generated by KAN-101 has the potential to significantly decrease the daily dietary burden of this disease, while the favorable safety profile will help ensure that KAN-101 can make the greatest impact for this population,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion. “In addition, to our knowledge, KAN-101 is the first agent to modulate gluten induced IL-2, an established biomarker associated with symptomatic responses to gluten exposure in celiac patients. We are very proud of our development of KAN-101, which leads our efforts to make a meaningful difference in the lives of individuals with autoimmune disease.”

Anokion is currently conducting a Phase 1b/2 clinical trial, ACeD-it, of KAN-101 in individuals with celiac disease. The company plans to initiate the Phase 2 portion in the third quarter of 2023, with initial data expected in the first half of 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.

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