Swiss biotechnology company Anokion has begun patient dosing in its Phase I clinical trial of antigen-specific drug candidate ANK-700 for treating individuals with relapsing remitting multiple sclerosis (RRMS).
Named ‘Multiple Sclerosis Study of ANK-700 to Assess Safety and Immune Tolerance (MoveS-it Study)’, the randomised, double-blind, placebo-controlled, first-in-human trial will assess the safety and tolerability of single and multiple ascending doses of ANK-700.
It will enrol up to 40 patients at up to ten sites in the US.
In Part A first-in-human study, subjects will be given a single dose of ANK-700 while in Part B, they will receive three doses of either ANK-700 or placebo.
Safety and tolerability will form the study’s trial primary endpoint while pharmacokinetics (PK) of ANK-700, the secondary endpoint. Anokion will also evaluate other exploratory endpoints such as assessments of immunological biomarker responses.
Anokion president and CEO Deborah Geraghty said: “Multiple sclerosis is a devastating disease that interferes with the brain’s ability to tell the body how to operate, with no curative options.
“We are thrilled to start this study with ANK-700, our second product candidate to enter clinical development in the last year.
“Backed by promising preclinical data in mouse models of MS, we believe ANK-700 has the potential to slow down and even stop disease progression in individuals with MS.”
MS is a demyelinating disease of the central nervous system, in which the myelin sheath in the brain and spinal cord are attacked by the body’s immune system.
The drug candidate induces antigen-specific tolerance to myelin-based autoantigens to re-educate the immune system for lowering neuroinflammation in the brain and spinal cord.
Last September, the US Food and Drug Administration (FDA) accepted Anokion’s Investigational New Drug (IND) application for ANK-700 to treat MS.