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Anokion Announces Initiation of Multiple-Ascending Dose Portion of its Phase 1 Clinical Trial with KAN-101 for the Treatment of Celiac Disease

CAMBRIDGE, Mass. & LAUSANNE, Switzerland–()–Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced that the company has initiated patient dosing in the multiple ascending dose (MAD) portion of its ACeD study (Assessment of KAN-101 in Celiac Disease), a Phase 1 clinical trial evaluating KAN-101 for the treatment of individuals with celiac disease. Initiation of the MAD cohort enrollment follows completion of the first two single-ascending dose (SAD) 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.

Celiac disease is a serious autoimmune disorder that results in severe and life-altering symptoms in patients when not managed properly. With no approved treatments today, symptoms can only be managed through a burdensome, gluten-free diet,” said Deborah Geraghty, Ph.D., president and chief executive officer of Anokion. “We are excited to advance our Phase 1 trial to the MAD portion, which will provide important information on the potential effects of repeat dosing of KAN-101 in our target patient population. By restoring natural immune tolerance, we believe KAN-101 could significantly impact the treatment of patients with celiac disease, and we look forward to assessing initial data and advancing this program later this year.”

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.

Additional information about the ACeD trial can be found at: www.ACeDtrial.com

About KAN-101

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.

About Celiac Disease

Celiac disease is a genetically driven, serious autoimmune disease where inappropriate immune responses to gluten peptides lead to damage of the small intestine.1 The prevalence of celiac disease in adults is approximately 0.4–0.95% in the United States and 1–2% in Europe.2 Celiac disease can cause severe symptoms including abdominal pain, diarrhea, nausea and vomiting.3 Long-term complications of celiac disease may include weight loss, osteoporosis, neurological problems and reproductive issues.4 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.5

About Anokion

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. For more information, please visit http://www.anokion.com/.

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1
www.celiac.org
2 Dubé, C. et al. Gastroenterology 128 (Suppl. 1), S57-S67 (2005)

3 www.nationalceliac.org
4 https://www.niddk.nih.gov/health-information/digestive-diseases/celiac-disease/symptoms-causes (accessed February 9, 2020)

5 www.celiac.org

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