Phase 1b/2 Clinical Trial of KAN-101 in Patients with Celiac Disease Underway

New Pharmacodynamic and Pharmacokinetic Data to be Presented Today During Digestive Disease Week 2023

Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced favorable new pharmacodynamic and pharmacokinetic data from the company’s completed Phase 1 clinical trial evaluating KAN-101 as a treatment for celiac disease. The findings will be presented today in an oral presentation from 10:45 – 11:00 a.m. CT titled “Pharmacodynamic Demonstration of Immunological Tolerance Induced by KAN-101, A Novel Liver-Targeted Therapy for Celiac Disease, Persists Following Drug Clearance,” at Digestive Disease Week 2023.

Anokion’s completed Phase 1 ACeD (Assessment of KAN-101 in Celiac Disease) Trial was a randomized, double-blind, placebo-controlled study in 41 individuals with celiac disease on a gluten-free diet, in both single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts.

“We’re excited to share these new data from our Phase 1 trial, which further establish that KAN-101 induces immune tolerance to gluten in people with celiac disease,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion. “As a highly burdensome condition with no disease-modifying therapies available today, KAN-101 could be a game changer for patients, with durable treatment effects observed following administration. We appreciate the continued enthusiasm for KAN-101 by the patient and physician community, and I am proud of the execution of the ACeD development program by the Anokion team. This is an important time for us as a company, with a growing body of data that validate our platform and scientific approach, as well as the therapeutic opportunity for KAN-101 as a novel treatment for a large patient population. We look forward to maintaining this level of progress in the months ahead.”

As reported in a previous presentation, findings from ACeD demonstrated that treatment with KAN-101 was safe and tolerated and induced functional tolerance of gliadin-specific T cells following gluten challenge. Today’s findings build on the data from the MAD portion of the trial, in which patients were randomized three to one to receive three administrations of KAN-101 at one of three dose levels: 0.15, 0.3, and 0.6 mg/kg or placebo on days 1, 4 and 7 followed by a 3-day oral gluten challenge starting on day 15. Plasma samples were collected on day 1 and 7 for pharmacokinetic analysis of KAN-101. Findings from this analysis showed that:

• KAN-101 was cleared from systemic circulation within approximately six hours across dose levels, while prolonged pharmacodynamic effects were observed for up to three weeks after treatment
• Gliadin-specific, tetramer+ T cells were increased by KAN-101, displaying an exhausted, functionally anergic phenotype and did not expand further after gluten challenge
• Administration of KAN-101 followed by gluten challenge led to dose-dependent modulation of gluten induced cytokines, including IL-2, which was not seen in the placebo arm

Based on the data from the Phase 1 trial, Anokion initiated its Phase 1b/2 clinical trial, ACeD-it, of KAN-101 in patients with celiac disease in late 2022. The company plans to initiate the Phase 2 portion in 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 http://www.anokion.com/.

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