Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine
AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting the calcitonin gene-related peptide (CGRP) receptor that is believed to transmit signals that can cause incapacitating pain.
In the trial, 483 patients were randomized to subcutaneous monthly placebo or AMG 334 (7 mg, 21 mg or 70 mg) in a 3:2:2:2 ratio, respectively. Patients had a mean baseline of 8.7 migraine days per month. The primary endpoint was the change from baseline in monthly migraine days at week 12. Patients randomized to the 70 mg dose group observed a statistically significant 3.4-day reduction in monthly migraine days compared with 2.28 days observed in the placebo group (p=0.021).
"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said
Secondary study endpoints included a 50 percent responder rate, monthly migraine attacks, and safety and tolerability. Key exploratory endpoints included change in monthly headache days and change in monthly acute migraine-specific medication use days. AMG 334 demonstrated a statistically significant increase in the 50 percent responder rate compared with placebo (47 percent vs. 30 percent, respectively). Furthermore, reductions in monthly headache days (-3.54 vs. -2.39) and monthly migraine-specific medication use days (-1.64 vs. -.69) were also statistically significant in patients taking the 70 mg AMG 334 dose compared with placebo, respectively.
The dose tolerability profile of AMG 334 was similar to placebo across all dosing groups. The most commonly reported adverse events included fatigue, influenza, nasopharyngitis, arthralgia and back pain. No Grade 4 or 5 adverse events were reported.
Migraine has been declared one of the top 10 most disabling conditions in the world, with more than 10 percent of the worldwide population suffering from the condition.1 More complex than just a headache, migraines involve incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or other sensory disturbances.2 Migraine has a tremendous impact on patients' everyday lives, including work productivity and social interactions.3,4 Approximately 50 percent of people living with migraine will go undiagnosed.5
About AMG 334
AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits the CGRP receptor, rather than CGRP itself, which is believed to transmit signals that can cause incapacitating pain.
AMG 334 is currently under investigation in several large global, randomized, double-blind, placebo-controlled studies to evaluate its safety and efficacy in migraine prevention.
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1 Vos et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
4 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated with the onset and remission of chronic daily headache in a population-based study. Pain. 2003 Nov: 106(102:81-9).
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