Currently recruiting at a single site in Tennessee, the trial (NCT04602390) is expected to enroll up to 40 patients with relapsing-remitting MS (RRMS) at up to 10 clinical sites in the U.S. More information on contacts and locations is available here.
“We are thrilled to start this study with ANK-700,” Deborah Geraghty, PhD, president and CEO of Anokion, the therapy’s developer, said in a press release. “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.”
The immune system is responsible for defending the body against bacteria, viruses, and other invaders. Immune tolerance is what allows the immune system to distinguish invaders from the body’s own molecules or tissues.
MS is an autoimmune disease caused by loss of immune tolerance against myelin proteins, causing the immune system to attack and damage this protective sheath in the brain and spinal cord.
Myelin is a fatty substance that covers never fibers and enables an efficient transmission of electrical impulses between nerve cells. Its loss leads to nerve cell degeneration and a range of symptoms that characterize MS.
ANK-700 was designed to “re-educate” the immune system of people with MS and restore immune tolerance, enabling immune cells to recognize myelin proteins as “self” and leave them unharmed.
This is accomplished by modulating immune tolerance-associated processes in the liver. Specifically, ANK-700 is thought to affect a subset of immune cells called T-cells, which are believed to be involved in the development of MS.
Studies in mice and non-human primate models of MS have shown the therapy was able to prevent disease onset or reduce disease activity, depending on when it was administered.
The Phase 1 clinical trial, authorized by the U.S. Food and Drug Administration in September, will evaluate the safety and tolerability of ANK-700 in people with RRMS, ages 18 to 55, who are not currently receiving disease-modifying treatments or using fumarate drugs — dimethyl fumarate (sold as Tecfidera, among others) or Vumerity (diroximel fumarate).
Dubbed MoveS-it, the trial is divided into two parts. First, patients will receive one of three doses of ANK-700 in a single intravenous (into-the-vein) infusion. The second part will investigate three infusions of ascending doses of ANK-700 or placebo.
The main goal is to determine the treatment’s safety and tolerability, as measured by the incidence of treatment-emergent side effects, and ANK-700 pharmacokinetics — how it moves through and out of the body — will be investigated as a secondary measure. Researchers also will be looking for immune biomarkers.
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