Anokion receives FDA Clearance

Based in Ecublens (VD), Anokion is developing a new therapy for treating rare autoimmune diseases such as celiac disease, multiple sclerosis and type 1 diabetes by restoring normal immune tolerance. 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. Its lead antigen-specific drug candidate is KAN-101 for treating celiac disease.

The U.S. Food & Drug Administration (FDA) has accepted Anokion's Investigational New Drug (IND) application for KAN-101. With the new achievement, the biotech company plans to initiate its multi-centre 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, 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 achieve 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 the initiation of Phase 1 clinical program.

(Press release/ran)