Allergan says its CGRP receptor antagonist atogepant has hit its primary target in a Phase IIb/III trial assessing its efficacy in preventing episodic migraine.
Data from the Phase IIb/III CGP-MD-01 trial show that all doses and regimens of the drug tested significantly reduced the monthly migraine/probable migraine (MPM) headache days in patients versus placebo.
The drug also fared well with regard to tolerability, with the most common adverse events found to be nausea, fatigue, constipation, nasopharyngitis, and urinary tract infection.
There was no signal of liver toxicity with atogepant in this study with daily administration over 12 weeks, and the drug had a liver safety profile similar to that of placebo, the firm stressed.
"The positive results from this study show that oral atogepant has a compelling profile relative to other treatment options on the market and in development for the prevention of migraine. We are excited about the prospects for this product and rapidly moving to the next stage of development," said Bill Meury, chief commercial officer at Allergan.
"These exciting results demonstrate the potential for atogepant for a broad spectrum of migraine patients. The efficacy and safety across doses and dose regimens show promise in a patient population with high unmet treatment needs," said Dr Peter Goadsby, neurologist and Professor at Kings College, London and University of California, San Francisco.
"Results from this atogepant trial provide continued evidence for the clinical potential of oral CGRP antagonists and the substantial value of progressing research and developing new treatments for migraine patients."
Atogepant is the Dublin, Ireland-headquartered second orally-administered investigational CGRP receptor antagonist in development for migraine prevention, following ubrogepant, which reported two positive Phase III pivotal trial results earlier this year.