Daclizumab, a humanized IgG1 monoclonal antibody against CD25, is a subcutaneously administered agent on the market for the prevention of transplanted organ rejection. Investigators are comparing the drug with intramuscular interferon beta-1a as a treatment for MS in an ongoing phase III clinical trial. Previous studies raised concerns regarding daclizumab’s safety and tolerability.
Neurologists have long sought biomarkers of efficacy for MS therapies. Daclizumab appears to provide such a biomarker in the form of an increase in CD56 bright natural killer cells.
Other anti-CD20 monoclonal antibodies in development include ofatumumab, which is now marketed for the treatment of refractory chronic lymphocytic leukemia. A second, secukinumab, is an anti-interleukin-17 monoclonal antibody that showed efficacy in terms of MRI lesions in a small study. In addition, an anti-LINGO-1 monoclonal antibody in development is intended to stimulate myelin repair.
Dr. Coyle predicted that more efficacy biomarkers will emerge and that neuroprotection and CNS restoration will be fertile areas for drug development. “A high-efficacy monoclonal antibody, if it’s safe and convenient, could seize the market. The safety will be the critical issue,” she concluded.
—Bruce Jancin
IMNG Medical News