- Atogepant met primary endpoint for all doses and dose regimens
- Atogepant was well tolerated and there was no signal of hepatotoxicity with daily administration over 12 weeks
- Allergan plans to rapidly move into next phase of development
Allergan plc, (NYSE: AGN) announced on 6/11/2018 positive results from CGP-MD-01, a Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of orally administered atogepant. All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from baseline in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks. Atogepant is Allergan's second orally-administered investigational calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention. Atogepant follows ubrogepant, Allergan's first oral investigational CGRP antagonist for the acute treatment of migraine, which reported two positive Phase 3 pivotal trial results earlier this year. Allergan will continue with its phase 3 program for atogepant following discussions with regulatory authorities.
All active treatment groups demonstrated a statistically significant reduction from baseline in the primary efficacy parameter (10 mg QD vs placebo, p=0.0236; 30 mg QD vs placebo, p=0.0390; 60 mg QD vs placebo, p=0.0390; 30 mg BID vs placebo; p=0.0034, 60 mg BID vs placebo, p=0.0031). The reported p-values are adjusted for multiple comparisons by controlling the overall type I error rate of the study at 5%, 2-sided.
"We are extremely pleased to share these positive results for atogepant -- our first phase 2b/3 study in Episodic Migraine—which represent a tremendous opportunity in the prevention of migraine, with a convenient, oral dosage form that is currently unavailable," said David Nicholson, Chief Research and Development Officer, Allergan. "Allergan has been studying migraine treatment for decades and is committed to addressing unmet needs through product innovation for patients who are hopeful for new options that can make a true difference in their daily lives."
"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. "Allergan has one of the most innovative and deepest product lines for migraine in the industry, with Botox approved for the prevention of chronic migraine and oral atogepant and ubrogepant in development for the prevention and acute treatment of migraine."
In the CGP-MD-01 trial, atogepant was well tolerated. The most common adverse events were nausea, fatigue, constipation, nasopharyngitis, and urinary tract infection which were reported with a frequency >5% in at least 1 atogepant treatment arm and greater than placebo. There was no signal of hepatotoxicity with atogepant in this study with daily administration over 12 weeks. The liver safety profile for atogepant was similar when compared to placebo.
Atogepant is a novel, highly potent, orally-administered CGRP receptor antagonist in development for the prevention of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. It is chemically distinct from ubrogepant, Allergan's orally-administered CGRP receptor antagonist for the acute treatment of migraine, with a higher potency and longer half-life, making it suitable for preventive treatment.