Positive results from CGP-MD-01, a Phase IIb/III trial evaluating orally administered atogepant in patients with episodic migraine. Allergan.

Allergan plc , announced positive results from CGP-MD-01, a Phase IIb/III 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 III pivotal trial results earlier this year. Allergan will continue with its phase III program for atogepant following discussions with regulatory authorities.In study CGP-MD-01 834 U.S. adult patients were randomized (2:1:2:1:2:1) to placebo, 10-mg QD, 30-mg QD, 30-mg BID, 60-mg QD, and 60-mg BID respectively, and treated under double blind conditions 12 weeks for the prevention of episodic migraine. Efficacy analyses were based on the modified ITT (mITT) population of 795 patients. The primary efficacy endpoint was the change from baseline in mean monthly migraine/probable migraine (MPM) headache days across the 12-week treatment period. 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.Additional details and results from other endpoints are anticipated to be presented at upcoming scientific meetings.

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 greater than 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.