Axsome Therapeutics has commenced patient enrolment in the Phase III MOMENTUM clinical trial of its AXS-07 candidate for the acute treatment of migraine.
AXS-07 is an investigational, oral medicine made of MoSEIC meloxicam and rizatriptan. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug, while rizatriptan is a 5-HT1B/D agonist.
Meloxicam is a new molecular entity enabled using Axsome’s MoSEIC technology.
The randomised, double-blind, multi-centre, controlled Phase III trial is designed to evaluate the safety and efficacy of AXS-07 in approximately 875 participants.
MOMENTUM will only involve patients who experienced inadequate response to prior migraine treatments. Subjects will be treated with AXS-07, rizatriptan, meloxicam or placebo.
Axsome Therapeutics Clinical Development and Medical Affairs senior vice-president Cedric O’Gorman said: “Migraine exerts a considerable personal toll on the lives of patients and is the leading cause of neurological disability.
“AXS-07 was designed to overcome the limitations of currently available acute treatments. We look forward to advancing the MOMENTUM study and learning more about the potential of AXS-07 to treat this frequently debilitating condition.”
Co-primary endpoints of the MOMENTUM trial are the percentage of patients free from headache pain and those who no longer suffer from their most bothersome migraine-associated symptom, such as nausea or photophobia, two hours after dosing.
Axsome Therapeutics expects to report top-line data from the trial in the first quarter of next year. These results are intended to support the regulatory submission for approval of AXS-07 in the US.
According to the Centers for Disease Control, more than 37 million people in the US suffer from migraine, which is characterised by recurrent attacks of pulsating, often severe and disabling head pain.