THOUSAND OAKS, Calif., May 15, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first results from its global Phase 2, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine. The study met its primary endpoint of reducing monthly mean migraine days compared with placebo. The data were presented at the 17th Congress of the International Headache Society (IHC 2015) in Valencia, Spain.
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 Sean E. Harper, M.D., executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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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.
2 National Institute for Neurological Disorders and Stroke. Headache: Hope Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm. Accessed April 20, 2015.
3 Migraine Research Foundation. Migraine Fact Sheet. http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed April 17, 2015.
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).
5 National Headache Foundation. Facts About Migraine. Available: http://www.headaches.org/press/NHF_Press_Kits/Press_Kits_-_Facts_About_Migraine. Accessed March 27, 2015.
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