CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced that the U.S. Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for KAN-101, the company’s lead antigen-specific drug candidate. Anokion plans to initiate its multi-center Phase 1 study for KAN-101 in people with celiac disease in the first quarter of 2020.
“This first IND acceptance represents a significant milestone for Anokion, validating our unique approach to targeting natural immune pathways in the liver to re-educate the immune system and enabling our transition into a clinical-stage organization,” said John A. Hohneker, M.D., president and chief executive officer of Anokion. “We believe that KAN-101 has the potential to provide a durable, disease-modifying benefit in celiac disease, a lifelong condition with no available therapeutic intervention. Today’s milestone represents the beginning of what 2020 holds for us as we work to advance our novel immune tolerance pipeline into the clinic, report initial data this year and take further steps to achieving our mission of improving the trajectory of life for people with autoimmune diseases.”
In addition to developing KAN-101, Anokion, in collaboration with Bristol Myers Squibb, plans to file an IND for ANK-700, an antigen-specific treatment for patients with multiple sclerosis, in 2020, followed by initiation of a Phase 1 clinical program.
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/.