Anokion SA announced positive symptom data from its Phase 2 ACeD-it trial evaluating KAN-101 in individuals with celiac disease, marking a significant step forward in the development of a disease-modifying treatment for this autoimmune condition. The data indicate that KAN-101 reduces multiple gluten-induced symptoms and celiac-specific composite measures. The Phase 2 trial is a double-blind, placebo-controlled study. Preliminary analysis showed that KAN-101 demonstrated clinically meaningful reductions across multiple individual symptoms and celiac-specific patient reported outcome composite measures following gluten exposure at all dose levels. KAN-101 was safe and tolerated at all dose levels investigated.
The Phase 2 ACeD-it trial is designed to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of KAN-101 in individuals with celiac disease. The study included a gluten challenge after patients received treatment with either KAN-101 or a placebo to evaluate pharmacodynamic and exploratory endpoints.
KAN-101: A Novel Approach to Immune Tolerance
KAN-101 is a novel immune tolerance therapy that delivers an established gluten antigen to the liver and immune system using Anokion’s proprietary liver-targeting technology. This approach aims to rebalance the immune system by removing pathogenic T cells, rendering them non-responsive, and expanding regulatory T cell responses. The drug has been granted Fast Track Designation from the FDA in May 2023.
"The positive symptom data from the Phase 2 ACeD-it study represents a transformational new therapeutic milestone for individuals with celiac disease, who today have no disease-modifying treatment options available. To date, KAN-101 is the only product candidate to demonstrate clinically meaningful effects across multiple symptoms following gluten challenge," said Deborah Geraghty, Ph.D., chief executive officer of Anokion.
The Unmet Need in Celiac Disease Treatment
Celiac disease is a serious autoimmune disorder affecting millions worldwide. Currently, the only available treatment is a strict gluten-free diet, which can be challenging to maintain and may not fully alleviate symptoms for all patients. Even with a strict diet, individuals can still experience symptoms and intestinal damage from hidden or incidental gluten exposure.
"Celiac disease is a chronic autoimmune disorder that can result in severe, life-altering symptoms and long-term gut damage," said Knut Lundin, M.D, PhD, professor of medicine and consultant, at Oslo University Hospital. "By inducing immune tolerance, KAN-101 has the potential to offer a durable, disease-modifying treatment option for patients continuing to experience symptoms despite being on a gluten-free diet. Clinically meaningful reduction of multiple symptoms in response to gluten exposure remains elusive and I am highly encouraged by these data and look forward to Anokion’s continued advancement with this novel agent."
Collaboration and Future Development
Anokion has partnered with Pfizer Ignite to support the development of KAN-101, leveraging Pfizer’s resources and expertise to accelerate the progression of this potential new medicine. Topline data from both the Phase 2 ACeD-it and the Phase 2a SynCeD clinical trials are expected in the first half of 2025. Anokion anticipates sharing full data and analysis at a future scientific conference or publication.
