Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).

Anokion plans to initiate a multi-center, Phase 1 clinical trial of ANK-700 in people with MS by the end of this year.

“Multiple sclerosis remains a devastating disease that significantly impacts those who suffer from it, including family members and caregivers. Unfortunately, available interventions offer limited benefit and often do not address the underlying mechanisms that advance disease,” said Simon Cooper, M.B.B.S., chief medical officer of Anokion.

“By harnessing the natural immune tolerance pathways in the liver, ANK-700 aims to re-educate the immune system with a potentially transformative approach that induces antigen-specific tolerance to CNS autoantigens and treats neuroinflammation. This IND marks the second clinical-stage program in our pipeline, and we look forward to initiating enrollment in the Phase 1 trial with ANK-700 later this year.”

In preclinical models, Anokion has demonstrated that the tolerogenic T cell mechanisms induced by its potent, liver-targeting technology were effective at preventing or reducing disease pathology for MS.

In a mouse model of MS, a liver-targeting myelin oligodendrocyte glycoprotein (MOG) antigen induced pathogenic T cell anergy and deletion, resulting in protection from disease onset and therapeutic remission when tolerized during active disease. These preclinical data were consistent with functional and mechanistic findings in a non-human primate model, supporting the translational potential in treating MS with ANK-700.