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news.Amgen has reported positive interim results from its open-label extension of the global Phase II trial evaluating the safety and efficacy of AMG 334 for the prevention of episodic migraine.
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AMG 334 is a fully human monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that can cause incapacitating pain.
A total of 383 patients who entered the open-label portion of the double-blind, placebo-controlled trial received AMG 334 70mg monthly and experienced a sustained reduction in monthly migraine days at week 52.
The company said that at one year, patients receiving AMG 334 70mg experienced an average of a -4.9-day reduction from a baseline of 8.7 mean monthly migraine days, regardless of treatment received during the blinded phase.
Amgen Research and Development executive vice-president 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."
Currently, AMG 334 is being evaluated in several large global, randomized, double-blind, placebo-controlled trials to evaluate its safety and efficacy in migraine prevention.