US-based Amgen has reported positive interim results from its ongoing Phase II study of human monoclonal antibody, AMG33, to prevent episodic migraine.
AMG 334 is a fully human monoclonal antibody that is being developed to prevent migraine. It targets the calcitonin gene-related peptide (CGRP) receptor, which is expected to transmit signals that can cause incapacitating pain.
The trial is a double-blind and placebo-controlled study, which is assessing the safety and efficacy of AMG 334 for the prevention of episodic migraine.
According to the firm, patients who went into the open-label phase received AMG 334 70mg monthly and experienced a sustained reduction in monthly migraine days at week 52.
Amgen research and development executive vice-president Dr Sean Harper said: "These long-term data further demonstrate that AMG 334 provided meaningful benefit to these patients with fewer migraine days and more days with the ability to participate in work and social activities each month.
"The sustained safety and efficacy shown in this interim analysis adds to the growing body of evidence that reinforces the potential of AMG 334 for patients with this debilitating condition."
The open-label portion of the Phase II trial comprised 383 patients and received AMG 334 70mg starting at week 12 for up to 256 weeks.
Safety and tolerability were assessed monthly and this interim analysis comprises data up to week 52, while additional efficacy endpoints included the change in monthly migraine-specific medication use days and patient-reported outcomes using the Migraine Disability Assessment (MIDAS) questionnaire.
Image: One of the many buildings at Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.