Daclizumab is a humanised monoclonal antibody that binds to CD25, a receptor subunit that is expressed at low levels on resting T-cells and at high levels on T-cells that are thought to become activated in response to MS.
Daclizumab is believed to work by selectively targeting these activated T-cells without causing general T-cell depletion.
The trial, called Decide, is expected to investigate a subcutaneous formulation of Daclizumab intended for monthly administration, which can provide a new immunomodulatory approach for treating MS.
Decide is a Phase III, randomised, double-blind, active-comparator study expected to enroll approximately 1,500 RRMS patients in 28 countries.
Daclizumab is also being investigated in the ongoing Phase IIb registration-enabling Select trial, which is evaluating the efficacy and safety of monthly subcutaneous doses of either 150mg or 300mg of Daclizumab monotherapy.
Under the terms of the collaboration agreement, Biogen Idec is expected to make a $30m milestone payment to Abbott. This payment is due upon enrollment of the first patient in the Decide trial.
Ludwig Kappos, head of MS-research group at University Hospital, Basel, Switzerland, and lead investigator for the study, said: “The MS community is eager for new treatment approaches. As shown in previous studies, Daclizumab appears to selectively target immune cells that are thought to become activated in MS and cause damage to the central nervous system.”
Alfred Sandrock, senior vice president of neurology research and development at Biogen Idec, said: “The Decide study builds on the positive results we saw in the Choice trial, which showed that Daclizumab, when added to interferon beta, reduced MS lesions compared to interferon beta therapy alone.”
Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said: “Initiating the Phase III Decide trial is a tremendous milestone for the collaboration as it brings Daclizumab one step closer to becoming a new treatment option for patients with MS. We look forward to expanding our knowledge further with the Decide trial.”