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11.06.2018 14:05
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Allergan's Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial
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PR Newswire
DUBLIN, June 11, 2018
DUBLIN, June 11, 2018 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced 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.
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.
Primary endpoint: change from baseline in mean monthly migraine/probable migraine (MPM) headache days across 12-week treatment period – mITT population
| Statistic | Placebo | Atogepant | Atogepant | Atogepant | Atogepant | Atogepant |
| Baseline | ||||||
| Mean (Days) | 7.81 | 7.63 | 7.64 | 7.74 | 7.38 | 7.62 |
| Change from Baseline | ||||||
| LS Mean (SE) | -2.85 (0.23) | -4.00 (0.32) | -3.76 (0.23) | -3.55 (0.23) | -4.23 (0.35) | -4.14 (0.33) |
| Atogepant vs Placebo | ||||||
| Least Squares Mean Difference (SE) | | -1.15 (0.40) | -0.91 (0.33) | -0.70 (0.33) | -1.39 (0.42) | -1.29 (0.41) |
| Adjusted p-value | | 0.0236 | 0.0390 | 0.0390 | 0.0034 | 0.0031 |
| | | | | | | |
Additional details and results from other endpoints are anticipated to be presented at upcoming scientific meetings.
"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."
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 CGP-MD-01 Liver Safety Profile
| Parameter | Placebo | Atogepant | Atogepant | Atogepant | Atogepant | Atogepant | |
| ALT or AST (U/L) | | | | | | | |
| > 3 x ULN | 3/179 (1.7 %) | 2/92 (2.2%) | 1/180 (0.6%) | 3/181 (1.7%) | 1/84 (1.2%) | 1/88 (1.1%) | |
| > 5 x ULN | 3/179 (1.7%) | 0 | 0 | 1/181 (0.6%) | 0 | 0 | |
| > 10 x ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| > 20 x ULN | 0 | 0 | 0 | 0 | 0 | 0 | |
| Potential Hy's Law (ALT or AST > 3XULN and Bilirubin Total >2XULN and | 0 | 0 | 0 Werbung Mehr Nachrichten zur Allergan Aktie kostenlos abonnieren
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