Initiation of the MAD cohort enrollment follows completion of the first two single-ascending dose cohorts in the trial, with the third SAD cohort actively dosing patients.
KAN-101, Anokion's lead antigen-specific drug product candidate, aims to re-educate immune cells to not respond to gluten antigens.
The ACeD study is a randomized, double-blind, placebo-controlled Phase 1 trial that will enroll a total of up to 40 patients with celiac disease who are on a gluten free diet. The study is composed of two parts.
In Part A, patients enrolled will receive a single dose of KAN-101 across four SAD cohorts. Upon completion of the second SAD cohort, the company initiated Part B, in which patients enrolled will each receive three doses of either KAN-101 or placebo across three MAD cohorts.
The primary endpoint of the ACeD trial is to assess the safety and tolerability of KAN-101 in patients, and the secondary endpoint is to assess serum concentrations and pharmacokinetics of KAN-101.
Exploratory endpoints include assessing cytokines critical to both innate and adaptive immunity, T cell responses, as well as other serum cytokines and celiac disease symptoms in patients treated with KAN-101.
Anokion anticipates reporting preliminary safety and pharmacokinetic data from the SAD cohorts of ACeD later this year.
KAN-101, an investigational medicine being developed for the treatment of celiac disease, is currently being evaluated in a Phase 1 clinical trial (ACeD study).
KAN-101 encompasses a well-described gluten antigen implicated in driving the onset of celiac disease and is designed to re-educate the immune system by targeting the body's own natural immune pathways in the liver.
Anokion has generated preclinical data demonstrating potentially durable, disease-modifying benefit with its immune tolerance platform in multiple animal models of disease.
Celiac disease is a genetically driven, serious autoimmune disease where inappropriate immune responses to gluten peptides lead to damage of the small intestine.
The prevalence of celiac disease in adults is approximately 0.4–0.95% in the United States and 1–2% in Europe.
Celiac disease can cause severe symptoms including abdominal pain, diarrhea, nausea and vomiting.
Long-term complications of celiac disease may include weight loss, osteoporosis, neurological problems and reproductive issues.
The only treatment available for patients is maintaining a strict, lifelong gluten-free diet and limiting exposure to gluten proteins from wheat, barley and rye, which is oftentimes ineffective.
Anokion SA is a 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.
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